Actively Recruiting
Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for 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
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer. The main questions it aims to answer are: 1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will： 1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks. 2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles. 3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity. 4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.
CONDITIONS
Official 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, any gender.
- Diagnosed with locally advanced unresectable, recurrent unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Confirmed HER2 negativity (IHC 0/1+ or IHC 2+ with FISH/ISH negative).
- 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 per RECIST v1.1.
- Resolved acute toxicities from prior treatments to Grade 0-1 except certain non-safety risks.
- Adequate organ function based on hematology, biochemistry, 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.
- Ability and willingness to sign informed consent and comply with study procedures.
You will not qualify if you...
- Histological types other than adenocarcinoma, including squamous cell or undifferentiated carcinoma.
- Active malignant tumors other than the study tumor within the past 2 years, except certain cured localized cancers.
- Participation in other investigational drug studies within 4 weeks prior to first dose.
- Untreated or uncontrolled symptomatic CNS metastases.
- Uncontrolled pleural effusion, ascites, or moderate-to-large pericardial effusion.
- Weight loss exceeding 20% within 2 months before enrollment.
- Major surgery within 28 days before enrollment (except biopsy or port implantation).
- Recent immunosuppressive drug use or live vaccine administration within specified periods.
- Other malignant tumors within 5 years except certain localized cancers.
- Active autoimmune diseases requiring systemic therapy.
- Prior treatment with immune checkpoint inhibitors.
- Significant bleeding, thromboembolic events, or major vascular disease within recent months.
- Severe wounds, ulcers, or untreated fractures.
- Peripheral neuropathy greater than Grade 1.
- History of intestinal obstruction within 6 months unless resolved by surgery.
- Interstitial lung disease, pneumonitis, uncontrolled systemic diseases.
- Active tuberculosis, HIV/AIDS, or active hepatitis infections.
- Known allergy to study drugs or monoclonal antibodies.
- Poorly controlled cardiac conditions.
- Recent systemic antibiotic use or unexplained fever.
- History of organ transplantation.
- Psychotropic drug abuse or addiction.
- Other severe physical or mental conditions affecting participation or safety.
AI-Screening
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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
CONTACT
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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