Actively Recruiting
Phase II Study of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy in Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Led by Beijing Friendship Hospital · Updated on 2026-01-06
32
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining Iparomlimab and Tuvonralimab (QL1706) with SOX chemotherapy in patients who have not previously been treated for advanced or metastatic gastric cancer or gastroesophageal junction cancer. This Phase II clinical trial aims to measure the objective response rate (ORR) and assess how well patients tolerate this combination therapy. Participants will first undergo up to 3 weeks of screening before starting treatment. The treatment involves an induction phase of up to 6 cycles (each cycle lasting 3 weeks) where patients receive Iparomlimab and Tuvonralimab intravenously on Day 1, Oxaliplatin intravenously on Day 1, and oral S-1 twice daily for 14 days followed by a 7-day rest. After 6 cycles, those without disease progression or intolerable side effects will continue maintenance therapy with QL1706 and S-1 until disease advancement or unacceptable toxicity occurs. Throughout the study, tumor imaging (using CT or MRI) will be done every 6 weeks for the first 24 weeks, then every 9 weeks thereafter to monitor disease status. Safety is tracked through adverse event reporting, lab tests, and physical exams. After treatment ends, patients will have a 90-day safety follow-up and then ongoing survival follow-up every 2 months to collect information on survival and subsequent therapies. The study plans to enroll about 32 participants and may continue until the end of 2029.
CONDITIONS
Brief Title
Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Voluntarily agree to participate and sign informed consent
- Diagnosed with locally advanced unresectable, recurrent unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by imaging and pathology
- Confirmed negative HER2 overexpression or amplification
- No prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction cancer
- ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST v1.1
- Resolved acute toxicities from prior treatments to Grade 0-1
- Adequate organ function based on specific blood, liver, kidney, coagulation, and urine tests
- Life expectancy of at least 3 months
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during and 6 months after treatment
You will not qualify if you...
- Presence of squamous cell carcinoma, undifferentiated carcinoma, or other non-adenocarcinoma gastric cancer types
- Active malignant tumors within 2 years except certain cured skin, bladder, cervical, or breast cancers
- Participation in another investigational drug study within 4 weeks before dosing
- Untreated or uncontrolled central nervous system metastases
- Uncontrolled pleural effusion, ascites, or significant pericardial effusion
- Weight loss greater than 20% in the 2 months before enrollment
- Recent major surgery (within 28 days) or recent immunosuppressive drug use
- Vaccination with live vaccines within 28 days before or planned during treatment
- Other malignant tumors diagnosed within 5 years except some local cancers
- Active or suspected autoimmune diseases requiring systemic therapy
- Prior treatment with immune checkpoint inhibitors
- Recent significant bleeding or thromboembolic events
- Major vascular disease within 6 months
- Severe wounds, ulcers, fractures, or peripheral neuropathy above Grade 1
- History of intestinal obstruction within 6 months
- Interstitial lung disease, pneumonitis, or uncontrolled systemic diseases
- Active tuberculosis or serious allergies to study drugs
- HIV/AIDS or untreated active hepatitis
- Poorly controlled cardiac conditions
- Recent systemic antibiotic use or fever unrelated to tumor
- History of organ transplantation
- History of psychotropic drug abuse or addiction
- Other severe physical or mental conditions that increase risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Induction phase: 6 cycles of 3 weeks each; Maintenance phase: until disease progression or discontinuation
Participants receive combination therapy of Iparomlimab and Tuvonralimab (QL1706) with SOX chemotherapy in 3-week cycles. The induction phase includes 6 cycles combining all drugs. Afterward, participants without disease progression or intolerable toxicity continue maintenance therapy with QL1706 and S-1 until disease progression or discontinuation.
Treatment visits every 3 weeks with tumor assessments every 6 weeks for the first 24 weeks, then every 9 weeks
Duration - Safety follow-up for 90 days; survival follow-up every 2 months thereafter
After treatment ends, participants enter a safety follow-up period of 90 days and a survival follow-up period with assessments every 2 months for survival status and subsequent therapies.
Visits every 2 months during survival follow-up
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
W
Wei Deng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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