Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma Clinical Trial
Official title:
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial
| Verified date | November 2023 |
| Source | Ruijin Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
| Status | Active, not recruiting |
| Enrollment | 580 |
| Est. completion date | August 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0; - Plans to proceed to surgery following pre-operative chemotherapy. - Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. - Has adequate organ function. - Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. - Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. - Has life expectancy of greater than 12 months. Exclusion Criteria: - Uncontrolled hypertension ( systolic =140 mmHg or diastolic =90 mmHg despite antihypertensive therapy) - Known hypersensitivity to any of the study drugs or excipients. - Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); - Congenital or acquired immune deficiency (e.g. HIV infected) |
| Country | Name | City | State |
|---|---|---|---|
| China | Affiliated Hospital of Hebei University | Baoding | |
| China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | |
| China | Xiangya Hospital Central South University | Changsha | |
| China | Heping Hospital Affiliated to Changzhi Medical College | Changzhi | |
| China | Sichuan Cancer Hospital & Institute | Chengdu | |
| China | Sichuan Provincial People's Hospital | Chengdu | |
| China | The Affiliated Hospital of Guizhou Medical University | Guiyang | |
| China | Hainan Cancer Hospital | Haikou | |
| China | Cancer Hospital of the University of Chinese Academy of Sciences | Hangzhou | |
| China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | |
| China | Hefei Cancer Hospital, Chinese Academy of Sciences | Hefei | |
| China | Lanzhou University Second Hospital | Lanzhou | |
| China | Changhai Hospital | Shanghai | |
| China | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | |
| China | Liaoning Cancer Hospita & Institute | Shenyang | |
| China | The Fourth Hospital of Hebei Medical University | Shijiazhuang | |
| China | Jilin Guowen Hospital | Siping | |
| China | Shanxi Provincial Cancer Hospital | Taiyuan | |
| China | First Affiliated Hospital of Xi'an Jiaotong University | Xian | |
| China | Tangdu Hospital | Xian | |
| China | Yantai Yuhuangding Hospital | Yantai | |
| China | Henan Provincial Cancer Hospital | Zhengzhou | |
| China | Affiliated Hospital of Jiangsu University | Zhenjiang |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathological Complete Response (pCR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | ||
| Primary | Event-free Survival (EFS) | Up to approximately 2 years | ||
| Secondary | Major pathological response(MPR) | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | ||
| Secondary | Margin-free (R0) resection rate | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | ||
| Secondary | DFS | up to 2 years | ||
| Secondary | OS | up to 3 years | ||
| Secondary | Downstaging of N stage | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | ||
| Secondary | AEs | Up to approximately 18 months |