NCT07643623 Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
| NCT ID | NCT07643623 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. |
| Condition | Resectable Gastric/Gastroesophageal Junction Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 720 participants |
| Start Date | 2026-07-31 |
| Primary Completion | 2031-12-31 |
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 720 participants in total. It began in 2026-07-31 with a primary completion date of 2031-12-31.
⚠ 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 is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
Eligibility Criteria
Inclusion Criteria 1. Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Expected survival ≥ 6 months. 5. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible. 6. Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system. 7. Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection. Exclusion Criteria 1. Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization. 2. Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage. 3. History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator. 4. Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction. 5. Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption. 6. Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention. 7. Active uncontrolled bleeding or known bleeding diathesis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07643623 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Resectable Gastric/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 NCT07643623 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 NCT07643623 currently recruiting?
Yes, NCT07643623 is actively recruiting participants. Contact the research team at chunxian.hu@innoventbio.com for enrollment information.
Where is the NCT07643623 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07643623 clinical trial?
NCT07643623 is sponsored by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.. The trial plans to enroll 720 participants.