Actively Recruiting
SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure
Led by Jingdong Zhang · Updated on 2025-12-31
40
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To investigate the efficacy of SHR-1701 combined with Rivoceranib, with or without SHR-2554, in patients with gastric or gastroesophageal junction adenocarcinoma who have progressed on or were intolerant to first-line immunotherapy-containing treatment
CONDITIONS
Official Title
SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female.
- Confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
- Disease progression on or intolerance to prior treatment containing immune checkpoint inhibitor.
- HER2-negative expression.
- Willing to provide tumor tissue samples for biomarker analysis.
- At least one measurable lesion according to RECIST version 1.1.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate organ and bone marrow function, including hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 90 x 10^9/L, bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases), serum creatinine ≤ 1.5 x ULN, LVEF ≥ 50%, and QTc interval < 450 ms for males and < 470 ms for females.
- For patients not on therapeutic anticoagulation: INR ≤ 1.5 and APTT ≤ 1.5 x ULN; patients on stable full-dose anticoagulants are eligible.
- For women of childbearing potential: negative pregnancy test within 14 days prior to enrollment and agreement to use effective contraception during and 3 months after study.
- For male patients: surgical sterilization or agreement to use effective contraception during and 3 months after study.
- Recovery from prior therapy toxicities to Grade ≤ 1; surgical wounds healed completely.
- Voluntary participation with signed informed consent and ability to comply with study requirements.
You will not qualify if you...
- Gastrointestinal perforation or fistula within 6 months prior, or active gastrointestinal bleeding within 3 months.
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage.
- Known allergy to study drugs or their components.
- Treatment with other investigational agents within 4 weeks or 5 half-lives prior to study drug.
- Concurrent participation in another interventional clinical study.
- Any anticancer therapy within 2 weeks prior to study drug.
- Requirement for systemic corticosteroids >10 mg prednisone daily within 2 weeks prior.
- Prior anti-tumor or live vaccine within 4 weeks prior.
- Major surgery or significant trauma within 4 weeks prior.
- History or current evidence of leptomeningeal or active brain metastases (except stable treated brain metastases).
- Active or recent autoimmune disease requiring systemic treatment within 2 years, with specified exceptions.
- Immunodeficiency including HIV, organ transplant, or active hepatitis.
- Poorly controlled cardiovascular disease including heart failure NYHA Class II+, unstable angina, recent myocardial infarction, or uncontrolled arrhythmias.
- Severe infection or active pulmonary inflammation within 4 weeks prior.
- History of interstitial lung disease.
- Active tuberculosis or history within 1 year without treatment.
- Another malignancy within 5 years, except low-risk cancers.
- Pregnancy or breastfeeding.
- Any condition that may compromise safety or study compliance as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, China, 11000
Actively Recruiting
Research Team
Q
Qian Dong, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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