NCT07384234 SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
| NCT ID | NCT07384234 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-04-24 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion). 3. Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction. 4. No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.). 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 6. Normal function of major organs. Exclusion Criteria: 1. Known HER2-positive. 2. Previous history of gastric cancer surgery. 3. Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery. 4. Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.). 5. Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease. 6. Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
Contact & Investigator
Yanan Zheng
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT07384234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07384234 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07384234 currently recruiting?
Yes, NCT07384234 is actively recruiting participants. Contact the research team at ianzyn@163.com for enrollment information.
Where is the NCT07384234 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07384234 clinical trial?
NCT07384234 is sponsored by Ruijin Hospital. The principal investigator is Yanan Zheng at Ruijin Hospital. The trial plans to enroll 60 participants.