Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction

Sponsor
Yongxu Jia
Study ID
NCT07776639
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Iparomlimab and Tuvonralimab Injection (QL1706) — DRUG
    5 mg/kg intravenous infusion on Day 1 every 3 weeks.
  • S-1 — DRUG
    40 mg/m² orally twice daily on Day 1-14 every 3 weeks.
  • Oxaliplatin — DRUG
    100 mg/m² intravenous infusion on Day 1 every 3 weeks.
  • Docetaxel — DRUG
    40 mg/m² intravenous infusion on Day 1 every 3 weeks.

Study Details

This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). The study aims to further explore the efficacy and safety of iapalolimab plus DOS regimen for locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma will be enrolled. Each treatment cycle lasts 21 days. After 3-4 cycles, patients who are assessed as operable by investigators will undergo surgical resection, and postoperative pathological results will be evaluated. The primary outcome measure is the pathological complete response rate. Investigators will determine subsequent treatment regimens based on patients' pathological findings and routine clinical practice at the study center. Radiological assessment of tumor response is recommended every 2 cycles.

Key Dates

First listed
Aug 20, 2026
Start date
May 10, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706 combined with DOS neoadjuvant therapy
    Neoadjuvant combination therapy with QL1706 plus S-1, oxaliplatin and docetaxel (DOS) for locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma.

Primary Outcome Measure

Pathological Complete Response (pCR) rate [ Time Frame: Up to 24 weeks after completion of neoadjuvant therapy and surgical resection ]

Central Contacts

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