RecruitingPhase 1Phase 2NCT06766305

QL1706 Combined With SOX Used in Theperioperative Treatment

Phase Ib/II Clinical Study of QL1706 Combined With SOX Perioperative Treatment for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma


Sponsor

Xiangdong Cheng

Enrollment

54 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study consists of the following two phases: Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation. Phase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1. Preoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing QL1706 (an immunotherapy drug that blocks both PD-1 and CTLA-4 checkpoints) combined with a chemotherapy regimen (SOX: oxaliplatin + S-1) as a treatment given before and after surgery for locally advanced stomach or gastroesophageal junction cancer. **You may be eligible if...** - You have been diagnosed with stomach or gastroesophageal junction adenocarcinoma confirmed by biopsy - Your cancer is locally advanced (stage T3 or higher, or node-positive) but has not spread to distant organs - You have not received any prior treatment for this cancer - You are between 18 and 75 years old with an ECOG score of 0 or 1 - Surgery is planned after the initial treatment, and complete removal of the tumor (R0 resection) is expected **You may NOT be eligible if...** - You have already received chemotherapy, radiation, or surgery for this cancer - You have active autoimmune disease or have previously had severe immune-related side effects - You have other serious heart, lung, or organ conditions - Your expected survival is less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL1706 combined with SOX

QL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance (up to 1 year before and after surgery); Phase 1 (initial dose cohort) : QL1706 5mg/kg ;Phase 1 (dose escalation cohort):QL1706 7.5mg/kg ;Phase 2:QL1706 RP2D


Locations(1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, China

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NCT06766305


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