Gastric CancerPhase 2NCT06383559
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
A Phase 2 study testing Lenvatinib and Sintilimab in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Lenvatinib and Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Sep 2026
- 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
- Male or female patients ≥18 years old;
- Patients with advanced / metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, AFP ≥ 20ng / ml;
- No previous palliative systemic treatment;
- There are measurable metastatic lesions according to RECIST version 1.1;
- ECOG physical status score is 0 or 1；
- Normal organ function: Neutrophil count ≥ 1.2 × 109/L, Platelet count ≥ 100 × 109/L, Hemoglobin (HB) ≥ 80g/L, Total bilirubin ≤ 1.5mg/dl, AST and ALT ≤ 100 IU/L. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU/L, Creatinine ≤ 1.5 times* upper limit of normal, International standardization ratio (INR) ≤ 1.5;
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- Urinary protein: meet one of the following conditions Urinary protein (test paper method) is 2 + or less, Urinary protein/creatinine (UPC) ratio < 3.5, Determination of 24-hour urinary protein, urinary protein ≤ 3500mg;
- Before receiving treatment, the patient has recovered the adverse events related to chemotherapy, radiotherapy and surgery to grade 1 or below (CTCAE 5.0);
- For women with fertility potential with negative pregnancy test within 14 days before enrollment, male and female patients should agree to use appropriate contraceptive methods from the beginning of the first treatment to 120 days after the last treatment;
- Patients who can take oral drugs;
- Signed the informed consent.
Who cannot join
- 1. Patients who received surgery and radiotherapy within 2 weeks before enrollment; 2. Patients who have previously been treated with Lenvatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs; 3. Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg); 4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment; 5. Patients with symptomatic brain metastases; 6. Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months; 7. The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix) 8. The patients have severe (hospitalized) complications 9. Patients with a history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment; 10. Patients with active hepatitis; 11. Patients with a history of human immunodeficiency virus (HIV) infection; 12. Patients with symptoms or signs of active interstitial pulmonary disease; 13. Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases; 14. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; 15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; 16. Patients who received live vaccine < 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; 17. Pregnant or lactating women; 18. The investigator determined that the patient is not suitable to be the subject of this trial; 19. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Ting Deng, MD, 022-23340123 ext. 1053, xymcdengting@126.com
Yi Ba, MD, 022-23340123 ext. 1053, bayi@tjmuch.com
About this study
Official title: Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients, a Multi-center, Prospective, Single-arm Phase II Trial
This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (>=60kg, 200 mg; <60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.
- Conditions
- Gastric Cancer
- Being tested
- Lenvatinib and Sintilimab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib and SintilimabDrug
XELOX regimen combined with Sintilimab and Lenvatinib
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | XELOX regimen combined with Sintilimab and Lenvatinib Receives: Drug: Lenvatinib and Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the rate of patients with PR and CR
Measured: 24 months
Secondary outcomes (2)
OS
The time from the beginning of treatment to the time when the patient dies from any cause
Measured: 24 months
PFS
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383559
- Sponsor's protocol ID
- TJMUCH-GI-GC07
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients, a Multi-center, Prospective, Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT06383559
- Acronym / sponsor ID
- TJMUCH-GI-GC07
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Apr 2024 (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.
This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (>=60kg, 200 mg; <60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Lenvatinib and SintilimabXELOX regimen combined with Sintilimab and Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients ≥18 years old;
- Patients with advanced / metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, AFP ≥ 20ng / ml;
- No previous palliative systemic treatment;
- There are measurable metastatic lesions according to RECIST version 1.1;
- ECOG physical status score is 0 or 1；
Key exclusion criteria (1 listed)
- 1. Patients who received surgery and radiotherapy within 2 weeks before enrollment; 2. Patients who have previously been treated with Lenvatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs; 3. Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg); 4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment; 5. Patients with symptomatic brain metastases; 6. Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months; 7. The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix) 8. The patients have severe (hospitalized) complications 9. Patients with a history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment; 10. Patients with active hepatitis; 11. Patients with a history of human immunodeficiency virus (HIV) infection; 12. Patients with symptoms or signs of active interstitial pulmonary disease; 13. Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases; 14. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; 15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; 16. Patients who received live vaccine < 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; 17. Pregnant or lactating women; 18. The investigator determined that the patient is not suitable to be the subject of this trial; 19. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.
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 |
|---|---|---|
| Lenvatinib and SintilimabXELOX regimen combined with Sintilimab and Lenvatinib | Drug | Experimental arm |
Primary outcome
ORR
Time frame: 24 months
the rate of patients with PR and CR
2 secondary outcomes
OS
Time frame: 24 months
PFS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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 Lenvatinib and Sintilimab in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and 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 11 inclusion and 1 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 25 Apr 2024. 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?
Contact Ting Deng, MD (022-23340123 ext. 1053, xymcdengting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.