NCT06766305

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Xiangdong Cheng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancers
• Esophagogastric Junction Cancers

Interventions

Type	Name	Description
DRUG	QL1706 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

Timeline

• Start date: 2025-03-21
• Primary completion: 2026-02-28
• Completion: 2031-06-30
• First posted: 2025-01-09
• Last updated: 2025-06-17

Locations

1 site across 1 country: China