Advanced Gastroesophageal AdenocarcinomaPhase 2NCT05299476
CAPOX + Bevacizumab + Tislelizumab Treating PD-L1 CPS < 5 Locally Advanced or Metastatic GEA
A Phase 2 study testing CAPOX combined with bevacizumab and Tislelizumab in people with Advanced Gastroesophageal Adenocarcinoma and First-line Therapy, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS < 5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastroesophageal Adenocarcinoma, First-line Therapy, PDL1 CPS < 5
- What is being tested?
- CAPOX combined with bevacizumab and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 20 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the same time, patients voluntarily participated in the study and signed informed consent.
- Either male or female, aged 18 or older.
- Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination.
- Anyway, she has no previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
- PDL-1 CPS < 5, HER2 negative;
- Anyway, ECOG scores 0-1 on PS.Estimated survival ≥3 months;
Show all 20Show fewer
- Anyway, their vital organs function according to the following rules:
- Hemoglobin (HGB) ≥90g/L;
- Neutrophil count (ANC) ≥1.5×109/L;
- Platelet count (PLT) ≥80×109/L;
- ALT and AST≤2.5×ULN;ALT and AST≤5×ULN for liver metastasis;
- Total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN);
- Serum Cr≤1×ULN, endogenous creatinine clearance rate > 50ml/min (Cockcroft-Gault formula);
- Urinary protein < (++), or 24-hour urinary protein < 1.0g;
- Lent blood functions normally, without active bleeding or thrombotic disease:
- INR≤1.5×ULN;
- Partial thrombin time APTT≤1.5×ULN;
- Prothrombin time PT≤1.5×ULN;
- Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
- Anyway, people who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.
Who cannot join
- Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer.
- Known allergy to oxaliplatin, PD-1 mab, bevacizumab or pharmaceutical excipients;Or severe allergic reactions to other monoclonal antibodies;
- Chauvinist has any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy); Patients with complete remission of childhood asthma without intervention or vitiligo as adults may be included, but not those requiring medical intervention with bronchodilators;
- HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
- Lent has a history of HIV infection;
- Accuser spends 14 days prior to first using a study drug, regardless of nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/ day of prednisone or an equivalent pharmacophysiological dose of another corticosteroid);
Show all 17Show fewer
- A live attenuated vaccine was administered either four weeks before the first dose or during the study period;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known；
- Hypertension that cannot be controlled even with standard treatment (systolic blood pressure ≥160mmHg/ diastolic blood pressure ≥100mmHg);
- Either having poorly controlled cardiac clinical symptoms or disease, such as :(1) NYHA grade 2 or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, or (4) clinically significant supracventricular or ventricular arrhythmias requiring treatment or intervention;
- Patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding > 30 ml within 3 months), were evaluated by a physician who agreed to spend time on an endoscopic evaluation, which was subject to endoscopic evaluation.
- Either a thromboembolic event (including a stroke event and/or a transient ischemic attack) occurs within 6 months;
- Participates in another clinical trial, or participates in any other drug clinical study within four weeks, or at least five half-lives since the last study drug was taken;
- At the same time, participants in the Study underwent anti-tumor therapy including chemotherapy, radiotherapy and immunotherapy within 4 weeks prior to drug administration.
- At the same time, participants received palliative radiotherapy for bone metastasis within 2 weeks prior to the beginning of drug administration. Radiation therapy for other sites within the first 4 weeks;
- Regardless, toxicity from previous anti-tumor therapy does not return to CTCAE [version 5.0] level 0-1, as shown in the following.Except: a. hair loss;B. Pigmentation;C. Long-term toxicity caused by radiotherapy could not be recovered according to the judgment of researchers;
- Other conditions that the investigator deems inappropriate for inclusion;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Open Phase II Trial of CAPOX Combined With Bevacizumab Combined With Tislelizumab in First-line Treatment of PDL1 CPS < 5 Locally Advanced or Metastati Gastroesophageal Adenocarcinoma
his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS < 5.
This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy.
Read more
The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled.
Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death.
After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
- Being tested
- CAPOX combined with bevacizumab and Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPOX combined with bevacizumab and TislelizumabDrug
Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 4-8 cycles; Capecitabine: oral administration, 2g/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Bevacizumab was administered intravenously (without prophylaxis) at 7.5mg/kg. The first infusion was 90min, the second infusion was 60min, and each infusion was 30 min. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.
Tislelizumab is administered intravenously (without prophylaxis) at a fixed dose of 200mg. Each infusion was 30 min (no less than 20 min, no more than 60 min), and the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| CAPOX combined with bevacizumab and Tislelizumab | Experimental | Not described Receives: Drug: CAPOX combined with bevacizumab and Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival
Probability of disease-free progression within 6 months in patients with complete remission and in patients with partial remission or disease progression
Measured: Six months from the start of treatment
Secondary outcomes (6)
ORR（Objective Response Rate）
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.
Measured: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
PFS（progression-free survival）
Time from randomness to the first occurrence of disease progression or death from any cause.
Measured: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
OS（Overall Survival)
Time from randomization to death from any cause
Measured: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
Time to Response (TTR)
TTR was defined as the time from randomization to the first occurrence of CR or PR.
Measured: From enrollment to the end of treatment at 8 weeks
Adverse Event
The dose suspension rate and dose termination rate caused by adverse events were determined according to NCI-CTCAE V5.0 standard
Measured: Safety visits were made before medication in each treatment cycle day1(every cycle is 21days)
Duration of Response (DOR)
duration of response (DOR) defined as the period between the first objective response and the first documented PD or death of any cause.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start25 Apr 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299476
- Sponsor's protocol ID
- S2021-642-01
- Status last verified
- Apr 2024
- First submitted
- 1 Mar 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Runge TM, Abrams JA, Shaheen NJ. Epidemiology of Barrett's Esophagus and Esophageal Adenocarcinoma. Gastroenterol Clin North Am. 2015 Jun;44(2):203-31. doi: 10.1016/j.gtc.2015.02.001. Epub 2015 Apr 9.
PubMed 26021191Hur C, Miller M, Kong CY, Dowling EC, Nattinger KJ, Dunn M, Feuer EJ. Trends in esophageal adenocarcinoma incidence and mortality. Cancer. 2013 Mar 15;119(6):1149-58. doi: 10.1002/cncr.27834. Epub 2012 Dec 11.
PubMed 23303625Kanat O, O'Neil B, Shahda S. Targeted therapy for advanced gastric cancer: A review of current status and future prospects. World J Gastrointest Oncol. 2015 Dec 15;7(12):401-10. doi: 10.4251/wjgo.v7.i12.401.
PubMed 26690491De Vita F, Di Martino N, Fabozzi A, Laterza MM, Ventriglia J, Savastano B, Petrillo A, Gambardella V, Sforza V, Marano L, Auricchio A, Galizia G, Ciardiello F, Orditura M. Clinical management of advanced gastric cancer: the role of new molecular drugs. World J Gastroenterol. 2014 Oct 28;20(40):14537-58. doi: 10.3748/wjg.v20.i40.14537.
PubMed 25356019Orditura M, Galizia G, Sforza V, Gambardella V, Fabozzi A, Laterza MM, Andreozzi F, Ventriglia J, Savastano B, Mabilia A, Lieto E, Ciardiello F, De Vita F. Treatment of gastric cancer. World J Gastroenterol. 2014 Feb 21;20(7):1635-49. doi: 10.3748/wjg.v20.i7.1635.
PubMed 24587643Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.
PubMed 34102137Hagi T, Kurokawa Y, Kawabata R, Omori T, Matsuyama J, Fujitani K, Hirao M, Akamaru Y, Takahashi T, Yamasaki M, Satoh T, Eguchi H, Doki Y. Multicentre biomarker cohort study on the efficacy of nivolumab treatment for gastric cancer. Br J Cancer. 2020 Sep;123(6):965-972. doi: 10.1038/s41416-020-0975-7. Epub 2020 Jul 3.
PubMed 32616848Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.
PubMed 30566590Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.
PubMed 31378459Zhang T, Song X, Xu L, Ma J, Zhang Y, Gong W, Zhang Y, Zhou X, Wang Z, Wang Y, Shi Y, Bai H, Liu N, Yang X, Cui X, Cao Y, Liu Q, Song J, Li Y, Tang Z, Guo M, Wang L, Li K. The binding of an anti-PD-1 antibody to FcgammaRIota has a profound impact on its biological functions. Cancer Immunol Immunother. 2018 Jul;67(7):1079-1090. doi: 10.1007/s00262-018-2160-x. Epub 2018 Apr 23.
PubMed 29687231Song Y, Gao Q, Zhang H, Fan L, Zhou J, Zou D, Li W, Yang H, Liu T, Wang Q, Lv F, Guo H, Yang L, Elstrom R, Huang J, Novotny W, Wei V, Zhu J. Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study. Leukemia. 2020 Feb;34(2):533-542. doi: 10.1038/s41375-019-0545-2. Epub 2019 Sep 13.
PubMed 31520078Desai J, Deva S, Lee JS, Lin CC, Yen CJ, Chao Y, Keam B, Jameson M, Hou MM, Kang YK, Markman B, Lu CH, Rau KM, Lee KH, Horvath L, Friedlander M, Hill A, Sandhu S, Barlow P, Wu CY, Zhang Y, Liang L, Wu J, Paton V, Millward M. Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. J Immunother Cancer. 2020 Jun;8(1):e000453. doi: 10.1136/jitc-2019-000453.
PubMed 32540858Shen L, Guo J, Zhang Q, Pan H, Yuan Y, Bai Y, Liu T, Zhou Q, Zhao J, Shu Y, Huang X, Wang S, Wang J, Zhou A, Ye D, Sun T, Gao Y, Yang S, Wang Z, Li J, Wu YL. Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phase 1/2 study. J Immunother Cancer. 2020 Jun;8(1):e000437. doi: 10.1136/jitc-2019-000437.
PubMed 32561638Xu J, Bai Y, Xu N, Li E, Wang B, Wang J, Li X, Wang X, Yuan X. Tislelizumab Plus Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2020 Sep 1;26(17):4542-4550. doi: 10.1158/1078-0432.CCR-19-3561. Epub 2020 Jun 19.
PubMed 32561664Van Cutsem E, de Haas S, Kang YK, Ohtsu A, Tebbutt NC, Ming Xu J, Peng Yong W, Langer B, Delmar P, Scherer SJ, Shah MA. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2119-27. doi: 10.1200/JCO.2011.39.9824. Epub 2012 May 7.
PubMed 22565005
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open Phase II Trial of CAPOX Combined With Bevacizumab Combined With Tislelizumab in First-line Treatment of PDL1 CPS < 5 Locally Advanced or Metastati Gastroesophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05299476
- Acronym / sponsor ID
- S2021-642-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS < 5.
This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy.
The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled.
Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death.
After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPOX combined with bevacizumab and Tislelizumab | Experimental | Drug: CAPOX combined with bevacizumab and Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- At the same time, patients voluntarily participated in the study and signed informed consent.
- Either male or female, aged 18 or older.
- Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination.
- Anyway, she has no previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
- PDL-1 CPS < 5, HER2 negative;
Key exclusion criteria (17 listed)
- Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer.
- Known allergy to oxaliplatin, PD-1 mab, bevacizumab or pharmaceutical excipients;Or severe allergic reactions to other monoclonal antibodies;
- Chauvinist has any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy); Patients with complete remission of childhood asthma without intervention or vitiligo as adults may be included, but not those requiring medical intervention with bronchodilators;
- HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
- Lent has a history of HIV infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPOX combined with bevacizumab and TislelizumabOxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 4-8 cycles; Capecitabine: oral administration, 2g/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Bevacizumab was administered intravenously (without prophylaxis) at 7.5mg/kg. The first infusion was 90min, the second infusion was 60min, and each infusion was 30 min. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years. Tislelizumab is administered intravenously (without prophylaxis) at a fixed dose of 200mg. Each infusion was 30 min (no less than 20 min, no more than 60 min), and the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years. | Drug | CAPOX combined with bevacizumab and Tislelizumab |
Primary outcome
6-month progression-free survival
Time frame: Six months from the start of treatment
Probability of disease-free progression within 6 months in patients with complete remission and in patients with partial remission or disease progression
6 secondary outcomes
ORR（Objective Response Rate）
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
PFS（progression-free survival）
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
OS（Overall Survival)
Time frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 9 weeks (±7 days) after 1 year
Time to Response (TTR)
Time frame: From enrollment to the end of treatment at 8 weeks
Adverse Event
Time frame: Safety visits were made before medication in each treatment cycle day1(every cycle is 21days)
Duration of Response (DOR)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Results publication: PubMed 26021191Runge TM, Abrams JA, Shaheen NJ. Epidemiology of Barrett's Esophagus and Esophageal Adenocarcinoma. Gastroenterol Clin North Am. 2015 Jun;44(2):203-31. doi: 10.1016/j.gtc.2015.02.001. Epub 2015 Apr 9.
- Results publication: PubMed 23303625Hur C, Miller M, Kong CY, Dowling EC, Nattinger KJ, Dunn M, Feuer EJ. Trends in esophageal adenocarcinoma incidence and mortality. Cancer. 2013 Mar 15;119(6):1149-58. doi: 10.1002/cncr.27834. Epub 2012 Dec 11.
- Results publication: PubMed 26690491Kanat O, O'Neil B, Shahda S. Targeted therapy for advanced gastric cancer: A review of current status and future prospects. World J Gastrointest Oncol. 2015 Dec 15;7(12):401-10. doi: 10.4251/wjgo.v7.i12.401.
- Results publication: PubMed 25356019De Vita F, Di Martino N, Fabozzi A, Laterza MM, Ventriglia J, Savastano B, Petrillo A, Gambardella V, Sforza V, Marano L, Auricchio A, Galizia G, Ciardiello F, Orditura M. Clinical management of advanced gastric cancer: the role of new molecular drugs. World J Gastroenterol. 2014 Oct 28;20(40):14537-58. doi: 10.3748/wjg.v20.i40.14537.
- Results publication: PubMed 24587643Orditura M, Galizia G, Sforza V, Gambardella V, Fabozzi A, Laterza MM, Andreozzi F, Ventriglia J, Savastano B, Mabilia A, Lieto E, Ciardiello F, De Vita F. Treatment of gastric cancer. World J Gastroenterol. 2014 Feb 21;20(7):1635-49. doi: 10.3748/wjg.v20.i7.1635.
- Results publication: PubMed 34102137Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.
- Results publication: PubMed 32616848Hagi T, Kurokawa Y, Kawabata R, Omori T, Matsuyama J, Fujitani K, Hirao M, Akamaru Y, Takahashi T, Yamasaki M, Satoh T, Eguchi H, Doki Y. Multicentre biomarker cohort study on the efficacy of nivolumab treatment for gastric cancer. Br J Cancer. 2020 Sep;123(6):965-972. doi: 10.1038/s41416-020-0975-7. Epub 2020 Jul 3.
- Results publication: PubMed 30566590Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.
- Results publication: PubMed 31378459Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.
- Results publication: PubMed 29687231Zhang T, Song X, Xu L, Ma J, Zhang Y, Gong W, Zhang Y, Zhou X, Wang Z, Wang Y, Shi Y, Bai H, Liu N, Yang X, Cui X, Cao Y, Liu Q, Song J, Li Y, Tang Z, Guo M, Wang L, Li K. The binding of an anti-PD-1 antibody to FcgammaRIota has a profound impact on its biological functions. Cancer Immunol Immunother. 2018 Jul;67(7):1079-1090. doi: 10.1007/s00262-018-2160-x. Epub 2018 Apr 23.
- Results publication: PubMed 31520078Song Y, Gao Q, Zhang H, Fan L, Zhou J, Zou D, Li W, Yang H, Liu T, Wang Q, Lv F, Guo H, Yang L, Elstrom R, Huang J, Novotny W, Wei V, Zhu J. Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study. Leukemia. 2020 Feb;34(2):533-542. doi: 10.1038/s41375-019-0545-2. Epub 2019 Sep 13.
- Results publication: PubMed 32540858Desai J, Deva S, Lee JS, Lin CC, Yen CJ, Chao Y, Keam B, Jameson M, Hou MM, Kang YK, Markman B, Lu CH, Rau KM, Lee KH, Horvath L, Friedlander M, Hill A, Sandhu S, Barlow P, Wu CY, Zhang Y, Liang L, Wu J, Paton V, Millward M. Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. J Immunother Cancer. 2020 Jun;8(1):e000453. doi: 10.1136/jitc-2019-000453.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Advanced Gastroesophageal Adenocarcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAPOX combined with bevacizumab and Tislelizumab in people with Advanced Gastroesophageal Adenocarcinoma and First-line Therapy, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival (time frame: Six months from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299476, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.