NCT07026149
Recruiting
Phase 2
Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Phase II Trial
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pathological Complete Response
Overview
Brief Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
Arm 1
Experimental
Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin
Intervention: Apatinib+Camrelizumab+SOX (Drug)
Arm 1
Experimental
Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin
Intervention: Preoperative Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Pathological Complete Response
Time Frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Secondary Outcomes
- Local control rate(up to 2 years)
- AEs(Up to approximately 18 months)
- Total Pathological Complete Response (tpCR)(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- Major pathological response(MPR)(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- Margin-free (R0) resection rate(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- Lymph node status after neoadjuvant therapy (ypN staging)(Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment)
- DFS(up to 2 years)
- OS(up to 2 years)
Investigators
Study Sites (1)
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