UnknownPhase 2

To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

37 participantsStarted 2023-07

Plain-language summary

The Purpose of This Study is to Evaluate the Efficacy and Safety of Cadonilimab（AK104） in Combination With SOX as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years.
✓. Histologically or cytologically confirmed diagnosis of adenocarcinoma locate at gastroesophageal junction or stomach, advanced gastric or gastroesophageal junction cancer as assessed by ultrasonography and/or CT/MRI (cT3-T4a, N+, M0).
✓. Resectable gastric or gastroesophageal cancer, judged by surgeons in this study.
✓. No previous anti-tumor treatment.
✓. The expected survival is no less than 3 months.
✓. ECOG PS≤1.
✓. Adequate organ function including the following:
✓. Strict contraception.

Exclusion criteria

✕. Unable to comply with the research program or procedures.
✕. Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.
✕. Active autoimmune disease or history of refractory autoimmune disease.
✕. Receiving corticosteroid (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
✕. Active or clinically significant cardiac disease:
✕. Evidence or history of bleeding diathesis or coagulopathy.
✕. Grade 3 bleeding events 4 weeks before enrollment.
✕. Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.

What they're measuring

Pathological complete response rate (pCR)

Timeframe: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Trial details

NCT IDNCT05948449

SponsorSichuan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01

Contact for this trial

Jiankun Hu, M.D

+86-18980601504 hujiankun@wchscu.cn

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