Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Intervention / Treatment
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* Drug: Apatinib 250mg
* Drug: Camrelizumab
* Drug: S-1, Oxaliplatin
* Drug: Apatinib 500mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib and Camrelizumab and S-1 and Oxaliplatin<br> | Drug: Apatinib 250mg<br>* Apatinib 250mg<br>Drug: Camrelizumab<br>* Camrelizumab 200mg<br>Drug: S-1, Oxaliplatin<br>* S-1, Oxaliplatin, q3w<br>|
| Experimental: Apatinib and S-1 and Oxaliplatin<br> | Drug: S-1, Oxaliplatin<br>* S-1, Oxaliplatin, q3w<br>Drug: Apatinib 500mg<br>* Apatinib 500mg<br>|
| Active Comparator: S-1 and Oxaliplatin<br> | Drug: S-1, Oxaliplatin<br>* S-1, Oxaliplatin, q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological Complete Response (pCR) |  | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | 
| Event-free Survival (EFS) |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathological response(MPR) |  | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | 
| Margin-free (R0) resection rate |  | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | 
| DFS |  | up to 2 years | 
| OS |  | up to 3 years | 
| Downstaging of N stage |  | Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment | 
| AEs |  | Up to approximately 18 months |