Actively Recruiting
Clinical Study of SHR1701 with CAPOX and SHR2554 or Apatinib for First-line Treatment of Advanced Gastric Cancer
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2026-04-16
78
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new treatment options for advanced gastric cancer, focusing on patients who may not fully benefit from the current standard first-line treatment of immunotherapy combined with chemotherapy. This Phase 2 study aims to assess whether adding immunomodulatory EZH2 inhibitors or anti-angiogenic agents to this treatment can further improve outcomes for these patients. The study is sponsored by The First Affiliated Hospital of Zhengzhou University and targets adults aged 18 and older with advanced or metastatic gastric cancer. The study involves two experimental treatment groups. One group receives a combination of SHR1701, SHR2554, and CAPOX chemotherapy, while the other group receives SHR1701, Apatinib, and CAPOX chemotherapy. SHR1701 is given every three weeks at a dose of 1800 mg, SHR2554 is taken twice daily at 350 mg, Apatinib is taken once daily at 250 mg, and CAPOX chemotherapy includes capecitabine and oxaliplatin administered on a three-week cycle. The study does not use randomization or masking. Participants will be involved in regular assessments to monitor treatment response, including measuring tumor response using RECIST version 1.1 criteria up to one year. They will undergo imaging scans such as contrast-enhanced CT or MRI, blood tests, and clinical evaluations to ensure safety and effectiveness. The study includes monitoring of blood counts, liver and kidney function, and other health indicators. Participants will also provide blood and tissue samples for research purposes. The total duration and follow-up details align with evaluation of the overall response rate within one year of treatment initiation.
CONDITIONS
Brief Title
PD1/TGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent
- Age 18 years or older
- ECOG performance status score between 0 and 2
- Pathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Clinical staging of stage III-IV non-resectable locally advanced or metastatic disease
- No prior systemic therapy for advanced disease (neoadjuvant therapy allowed)
- Measurable lesions according to RECIST version 1.1
- Baseline blood and biochemical tests meet specified minimum values and limits
- No serious concurrent diseases with life expectancy less than 5 years
- Females of childbearing potential must have a negative pregnancy test and agree to contraception; males must agree to contraception
- Agree to provide blood and/or tissue specimens
You will not qualify if you...
- Pregnant or lactating women
- Known HER2 positive status
- Unresolved adverse events from previous treatments greater than Grade 1 (except alopecia)
- History of other cancers within 5 years, except certain cured skin or cervical cancers
- History of uncontrolled epilepsy, CNS diseases, or mental disorders affecting consent or medication adherence
- Clinically significant active heart disease or recent myocardial infarction
- Arterial or venous thrombotic events within 6 months
- Significant bleeding symptoms or bleeding tendencies within 3 months
- Known hereditary or acquired bleeding or clotting disorders
- Gastrointestinal obstruction or malabsorption affecting drug absorption
- Abnormal coagulation or receiving certain anticoagulant therapies
- Chemotherapy-induced neurotoxicity unsuitable for oxaliplatin use
- History of organ transplantation requiring immunosuppressive therapy
- Active ulcers, unhealed wounds, or fractures
- Uncontrolled hypertension
- Known hypersensitivity to study drugs or excipients
- Clinically symptomatic serous cavity effusions requiring management
- Active hepatitis or infections requiring antimicrobial therapy
- Interstitial lung diseases or active pulmonary infections
- Active or history of autoimmune diseases with potential recurrence except controlled conditions
- Skin diseases requiring systemic treatment, uncontrolled asthma, or other specified conditions unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive combination drug treatments including SHR1701 with CAPOX and either SHR2554 or Apatinib as first-line therapy for advanced gastric cancer.
Visits every 3 weeks corresponding with treatment cycles
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Y
Yongxu Jia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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