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This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab and chemotherapy | Experimental | Participants receive camrelizumab 200 mg intravenously (IV) on the first day (q3w), then oxaliplatin 130 mg/m^2, IV on the first day (q3w), and tegafur gimeracil oteracil potassium capsule 80 mg/m^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Three weeks as a course of treatment, a total of 8 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidences and types of adverse events | The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Disease-free survival (DFS) | 3 years |
| Overall survival (OS) | Overall survival (OS) | 3 years |
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Inclusion Criteria:
Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
The gender is not limited. Age: ≥ 18 years and ≤ 75 years old.
Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology.
Without evidence of distant metastatic disease before operation by imaging.
Received D2 or D2+ radical gastrectomy by open surgery (R0 resection).
Stage III gastric cancer confirmed by postoperative pathology (AJCC/UICC 8th TNM staging classification).
Participants with a performance status of 0 ~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.
Life expectancy ≥ 6 months.
The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of blood transfusion, albumin, recombinant human thrombopoietin or granulocyte stimulating factor):
A. Hematological function:
B. Hepatic function:
C. Renal function:
D. Coagulation function:
Female of childbearing age must meet requirements: urine pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is longer).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiren Yu | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40656603 | Derived | Jin H, Yu J, Gao Y, Liu X, Xu H, Jiang H, Zhou S, Xu N, Zheng Y, Shen Q, Zhao Z, Wu D, Zhang Q, Zhu K. Camrelizumab plus SOX chemotherapy as adjuvant therapy for pathological stage III gastric or gastroesophageal junction adenocarcinoma: a prospective, multicenter, single-arm, phase II trial. Ther Adv Med Oncol. 2025 Jul 10;17:17588359251355781. doi: 10.1177/17588359251355781. eCollection 2025. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Oxaliplatin | Drug | Oxaliplatin: 130 mg/m^2 IV for 2-6 hour in first day which will be administered at least 30 min after completion of camrelizumab administration, every 3 weeks. Repeated every 21 days, 21 days for a cycle. |
|
| Tegafur gimeracil oteracil potassium capsule | Drug | Tegafur gimeracil oteracil potassium capsule: 80 mg/m^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Repeated every 21 days. 21 days for a cycle. |
|
| Treatment completion rate | Percentage of participants who complete eight cycles of chemotherapy in combination with Camrelizumab. | 6 months |
| Lishui Central Hospital |
| Lishui |
| Zhejiang |
| 323000 |
| China |
| Taizhou Hospital | Taizhou | Zhejiang | 317000 | China |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325027 | China |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |