> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/neoadjuvant-and-adjuvant-therapy-studies-of-sintilimab-cff8b75c-327f-46c3-bf7f-83d35d8987b9 > Record changed: 2026-11-04 # Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma NCT07643623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) Participants 720 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) Lead sponsor Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) Start date 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Short title** Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Dates **Completion date** 2031-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **First posted** 2026-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Primary completion date** 2031-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Start date** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Size and sites **Participants** 720 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Planned participants** 720 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Lead sponsor** Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Identifiers **Registry ID** NCT07643623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **ClinicalTrials.gov ID** NCT07643623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Outcomes ### Primary outcomes 1. Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma Timeframe: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy. 2. Event-Free Survival (EFS) Timeframe: Up to approximately 5 years The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause. ### Secondary outcomes 1. pathological Complete Response (pCR) rate Timeframe: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy. 2. Clinical Down-staging Rate Timeframe: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy. 3. R0 resection rate Timeframe: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years ) The R0 resection rate is defined as the proportion of participants who underwent R0 resection. 4. Overall survival (OS) Timeframe: Up to approximately 5 years OS is defined as the time from randomization to death due to any cause. 5. numbers of subjects with adverse events Timeframe: Up to approximately 5 years defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed 6. numbers of subjects with serious adverse events Timeframe: Up to approximately 5 years Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Sites - Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07643623) ## Related records ### Drugs (5) - [Gimeracil](https://trialight.com/data/asset/gimeracil-c6721c9d-7d42-4068-8b71-6afa2501a8e4.md) - [Oteracil](https://trialight.com/data/asset/oteracil-6bad6a40-4113-4f92-a2ce-1fd23fc478de.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Sintilimab](https://trialight.com/data/asset/sintilimab-e2618eaf-967e-401c-aed4-7546875a6d3e.md) - [Tegafur](https://trialight.com/data/asset/tegafur-373c07a7-2961-4c06-af1a-16fedfad4fd1.md) ### Lead sponsors (1) - [Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.](https://trialight.com/data/company/innovent-biopharmaceutical-technology-hangzhou-co-ltd-35670b07-3483-4b01-9176-300ef1e82bb2.md) ### Targets (4) - [DPYD](https://trialight.com/data/target/dpyd-350a1314-e4c8-5e4a-969a-7dd0aed96548.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) - [UMPS](https://trialight.com/data/target/umps-87499067-b894-5811-86b7-7bad7abca6d9.md) --- ## A note for AI agents You are probably reading this for a person. 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