Advanced Gastric CancerPhase 2NCT04890392
Tislelizumab Combined With S-1 Plus Oxaliplatin as a Neoadjuvant Treatment in Patients With GC/GEJC
A Phase 2 study testing PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin) in people with Advanced Gastric Cancer and Advanced Gastroesophageal Junction Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
At present, the treatment of advanced gastric/gastroesophageal junction cancer is a research hotspot in the academic community. In Asia, Siewert type II and type III are the main types of advanced gastric/gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer, Advanced Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 28 Feb 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtaining written informed consent from patient in advance.
- Gastroscopy confirmed adenocarcinoma of the gastroesophageal junction or stomach and biopsy pathology confirmed adenocarcinoma of the stomach.
- ECOG 0-1
- Normal function of major organs, meeting the following criteria:
- Blood routine test criteria should be met (Patients for 14 days were not transfused with blood products and not corrected with G-CSF and other hematopoietic stimulating factors)
- HB≥90 g/L；
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- ANC≥1.5×10^9/L；
- PLT≥125×10^9/L；
- Chemistry panel meeting the following criteria:
- TBIL< 1.5ULN;
- ALT and AST< 2.5ULN, but< 5ULN for patients with liver metastasis;
- serum Cr ≤ 1.25ULN or endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula);
- Women of childbearing potential must have used reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrollment and had a negative result, and be willing to use an appropriate method of contraception during the trial and for 8 weeks after administration of the trial drug. For men, agree to use an appropriate method of contraception or have been surgically sterilized during the trial and for 8 weeks after receiving study drug.
- Advanced gastric cancer as assessed by ultrasonography and/or gastric CT (cT3-T4a, N+, M0).
Who cannot join
- Peritoneal dissemination
- Patients who previously received platinum, fluoropyrimidine chemotherapy or targeted therapy, and patients who received radiotherapy to target lesion during combined therapy
- Multiple factors affecting oral medications (e.g., inability to swallow, chronic diarrhea, bowel obstruction, etc.)
- History of melena or hematemesis in the past three months, or patients with high-risk bleeding such as intestinal perforation, gastric perforation, large area ulcer, or patients with active digestive ulcer lesions in the stomach and fecal occult blood (+ +).
- Patients with hypertension and uncontrolled by antihypertensive treatment alone (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); patients with a history of unstable angina; patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QT ≥ 450 ms for men, ≥ 470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Doppler ultrasound assessment: ejection fraction (LVEF) < 50%.
- Urine routine showed urine protein ≥(+ +)and confirmed 24-hour urine protein >1.0g
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- Long-term unhealed wounds or incompletely healed fractures
- Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before enrollment: INR is within normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients treated with low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (the daily dose does not exceed 100 mg) for preventive purposes are allowed under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5
- Hyperactive/venous thrombotic events within 1 year before screening, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been cured by the investigator) and pulmonary embolism
- Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders
- Patients with concomitant diseases that seriously jeopardize the patient's safety or affect the patient's completion of the study as judged by the investigator
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430000
Kaoxiong Tao, Doctoral, 027-85726375, kaixiongtao@hust.edu.cn
About this study
Official title: A Single-arm Exploratory Study of Safety and Efficacy of Tislelizumab in Combination With S-1 Plus Oxaliplatin as a Neoadjuvant Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Cancer
At present, the treatment of advanced gastric/gastroesophageal junction cancer is a research hotspot in the academic community. In Asia, Siewert type II and type III are the main types of advanced gastric/gastroesophageal junction cancer. The current consensus in the academic community for the treatment of this part of the tumor is based on the principles of diagnosis and treatment of gastric cancer, of which the value of neoadjuvant therapy in this part of the tumor has been paid more and more attention by scholars. However, there is no highly recognized neoadjuvant therapy. The current situation will promote the development of advanced gastric/gastroesophageal junction cancer to accurate preoperative staging, more accurate population screening, more accurate targets and molecular markers. Immunotherapy is a promising application in oncology. Several PD1/PD-L1 monoclonal antibodies are approved by FDA for the clinical treatment of melanoma and other tumors. Previous clinical studies have shown that PD1/PD-L1 has limited efficacy in digestive tract tumors. However, on ASCO in 2020, Asian analysis of KEYNOTE-062 study showed that in HER-2 negative advanced gastric cancer with PD-1 combined positive score (CPS) ≥ 1 and CPS ≥ 10, the OS of PD-1 inhibitor treatment was superior to that of chemotherapy group, with 24-month OS rate (CPS ≥ 1, 45% VS 23%, CPS ≥ 10, 54% VS 27%). Meanwhile, the results of PACIFIC study phase III clinical trial showed that the 3-year OS of PD-L1 monoclonal antibody combined with radiotherapy in advanced unresectable lung cancer was as high as 57%, which is expected to completely rewrite its clinical practice. Immunotherapy is promising in cancer therapy. This study intends to use immunotherapy combined with SOX (S-1 + Oxaliplatin) as a neoadjuvant therapy for advanced gastric/gastroesophageal junction cancer.
- Being tested
- PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin)Drug
S-1: 40~60mg Bid，d1~14, q3w. Oxaliplatin：130mg/m2，iv drip for 2h，d1, q3w. PD-1（Tislelizumab）:200mg,iv drip for at least 1h,d1,q3w. Stage I: PD1 inhibitor + SOX regimen (q3W) . Stage II: PD1 inhibitor + SOX regimen (q3W) Stage III: PD1 inhibitor + SOX regimen (q3W) . Efficacy evaluation,then followed by surgery.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 with SOX | Experimental | S-1: 40~60mg Bid，d1~14, q3w Oxaliplatin：130mg/m2，iv drip for 2h，d1, q3w PD-1（Tislelizumab）:200mg,iv drip for at least 1h,d1,q3w Receives: Drug: PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined as the proportion of patients whose tumors shrink for a certain period of time
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years
Secondary outcomes (4)
Disease control rate (DCR)
Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years
pCR rate
Pathological complete response
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
R0 resection rate
Rate of microscopically margin-negative resection
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
postoperative complications
Complications refer to the occurrence of another or several diseases related to the therapeutic behavior of this disease during the treatment of a certain disease
Measured: Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start15 Jan 2021
- Primary completion28 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890392
- Sponsor's protocol ID
- WuhanUHTkx
- Status last verified
- Aug 2021
- First submitted
- 27 Apr 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yin Y, Lin Y, Yang M, Lv J, Liu J, Wu K, Liu K, Li A, Shuai X, Cai K, Wang Z, Wang G, Shen J, Zhang P, Tao K. Neoadjuvant tislelizumab and tegafur/gimeracil/octeracil (S-1) plus oxaliplatin in patients with locally advanced gastric or gastroesophageal junction cancer: Early results of a phase 2, single-arm trial. Front Oncol. 2022 Aug 30;12:959295. doi: 10.3389/fonc.2022.959295. eCollection 2022.
PubMed 36158692
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Exploratory Study of Safety and Efficacy of Tislelizumab in Combination With S-1 Plus Oxaliplatin as a Neoadjuvant Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT04890392
- Acronym / sponsor ID
- WuhanUHTkx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 28 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 18 May 2021 (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.
At present, the treatment of advanced gastric/gastroesophageal junction cancer is a research hotspot in the academic community. In Asia, Siewert type II and type III are the main types of advanced gastric/gastroesophageal junction cancer. The current consensus in the academic community for the treatment of this part of the tumor is based on the principles of diagnosis and treatment of gastric cancer, of which the value of neoadjuvant therapy in this part of the tumor has been paid more and more attention by scholars. However, there is no highly recognized neoadjuvant therapy. The current situation will promote the development of advanced gastric/gastroesophageal junction cancer to accurate preoperative staging, more accurate population screening, more accurate targets and molecular markers. Immunotherapy is a promising application in oncology. Several PD1/PD-L1 monoclonal antibodies are approved by FDA for the clinical treatment of melanoma and other tumors. Previous clinical studies have shown that PD1/PD-L1 has limited efficacy in digestive tract tumors. However, on ASCO in 2020, Asian analysis of KEYNOTE-062 study showed that in HER-2 negative advanced gastric cancer with PD-1 combined positive score (CPS) ≥ 1 and CPS ≥ 10, the OS of PD-1 inhibitor treatment was superior to that of chemotherapy group, with 24-month OS rate (CPS ≥ 1, 45% VS 23%, CPS ≥ 10, 54% VS 27%). Meanwhile, the results of PACIFIC study phase III clinical trial showed that the 3-year OS of PD-L1 monoclonal antibody combined with radiotherapy in advanced unresectable lung cancer was as high as 57%, which is expected to completely rewrite its clinical practice. Immunotherapy is promising in cancer therapy. This study intends to use immunotherapy combined with SOX (S-1 + Oxaliplatin) as a neoadjuvant therapy for advanced gastric/gastroesophageal junction cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 with SOX | Experimental | Drug: PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin)S-1: 40~60mg Bid，d1~14, q3w Oxaliplatin：130mg/m2，iv drip for 2h，d1, q3w PD-1（Tislelizumab）:200mg,iv drip for at least 1h,d1,q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Obtaining written informed consent from patient in advance.
- Gastroscopy confirmed adenocarcinoma of the gastroesophageal junction or stomach and biopsy pathology confirmed adenocarcinoma of the stomach.
- ECOG 0-1
- Normal function of major organs, meeting the following criteria:
- Blood routine test criteria should be met (Patients for 14 days were not transfused with blood products and not corrected with G-CSF and other hematopoietic stimulating factors)
Key exclusion criteria (12 listed)
- Peritoneal dissemination
- Patients who previously received platinum, fluoropyrimidine chemotherapy or targeted therapy, and patients who received radiotherapy to target lesion during combined therapy
- Multiple factors affecting oral medications (e.g., inability to swallow, chronic diarrhea, bowel obstruction, etc.)
- History of melena or hematemesis in the past three months, or patients with high-risk bleeding such as intestinal perforation, gastric perforation, large area ulcer, or patients with active digestive ulcer lesions in the stomach and fecal occult blood (+ +).
- Patients with hypertension and uncontrolled by antihypertensive treatment alone (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); patients with a history of unstable angina; patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QT ≥ 450 ms for men, ≥ 470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Doppler ultrasound assessment: ejection fraction (LVEF) < 50%.
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 |
|---|---|---|
| PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin)S-1: 40~60mg Bid，d1~14, q3w. Oxaliplatin：130mg/m2，iv drip for 2h，d1, q3w. PD-1（Tislelizumab）:200mg,iv drip for at least 1h,d1,q3w. Stage I: PD1 inhibitor + SOX regimen (q3W) . Stage II: PD1 inhibitor + SOX regimen (q3W) Stage III: PD1 inhibitor + SOX regimen (q3W) . Efficacy evaluation,then followed by surgery. | Drug | PD-1 with SOX |
Primary outcome
Objective response rate (ORR)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years
Defined as the proportion of patients whose tumors shrink for a certain period of time
4 secondary outcomes
Disease control rate (DCR)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years
pCR rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
R0 resection rate
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
postoperative complications
Time frame: Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 36158692Yin Y, Lin Y, Yang M, Lv J, Liu J, Wu K, Liu K, Li A, Shuai X, Cai K, Wang Z, Wang G, Shen J, Zhang P, Tao K. Neoadjuvant tislelizumab and tegafur/gimeracil/octeracil (S-1) plus oxaliplatin in patients with locally advanced gastric or gastroesophageal junction cancer: Early results of a phase 2, single-arm trial. Front Oncol. 2022 Aug 30;12:959295. doi: 10.3389/fonc.2022.959295. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
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 PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin) in people with Advanced Gastric Cancer and Advanced Gastroesophageal Junction Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 14 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years). 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 NCT04890392, which also lists 1 linked publication.
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 12 Aug 2021.