Actively Recruiting
A Prospective, Single-Arm Trial Evaluating Fruquintinib Combined With Nab-Paclitaxel and Iparomlimab and Tuvonralimab as Second-Line Therapy in Advanced Gastric Cancer After Immunotherapy
Led by Dai, Guanghai · Updated on 2026-02-11
68
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new second-line treatment approach for patients with advanced or metastatic gastric cancer who have not responded to first-line immunotherapy. This trial focuses on patients whose cancer progressed during or after immunotherapy-containing regimens, addressing a significant need since current second-line options provide only limited benefit. Anti-angiogenic agents combined with immunotherapy and chemotherapy have shown promising preliminary results, motivating this study to evaluate a combination including fruquintinib, nab-paclitaxel, and a novel bispecific antibody. The study treatment involves a combination of fruquintinib taken orally daily at 3 mg, intravenous Iparomlimab and Tuvonralimab antibodies given at 5.0 mg/kg every three weeks, and albumin-bound paclitaxel administered intravenously at 250 mg/m2 every three weeks. After six cycles of this combination therapy, participants will continue maintenance treatment with fruquintinib plus the two antibodies until disease progression, unacceptable side effects, or other reasons for discontinuation. Treatment continues until progression or intolerable toxicity. Participants will be monitored over 24 months to assess progression-free survival as the primary outcome, along with secondary measures including objective response rate, disease control rate, and overall survival. Patients will undergo scheduled visits for treatment administration, clinical evaluations, and laboratory tests to assess safety and efficacy. The trial aims to gather comprehensive data on the treatment's impact and tolerability throughout the study period.
CONDITIONS
Brief Title
Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with gastric cancer or gastroesophageal junction cancer confirmed by pathology or cytology
- Experienced disease progression after first-line treatment with PD-1 or PD-L1 inhibitors
- Have measurable tumors according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1 indicating good overall health
- Expected to survive at least 3 months
- Adequate major organ function including blood counts, liver and kidney function, and normal coagulation
- For patients who can have children, use effective contraception during the study and for 3 months after
- Negative pregnancy test before starting the study
- Not breastfeeding
- Able and willing to provide informed consent and comply with study requirements
You will not qualify if you...
- History of gastrointestinal perforation or fistula within 6 months before starting treatment
- Uncontrolled fluid buildup around lungs or heart needing repeated drainage
- Allergic reactions to monoclonal antibodies, fruquintinib, or albumin-bound paclitaxel
- Severe adverse reactions to prior immunotherapy
- Previous treatment with CTLA4 inhibitors
- Use of other study medications within 4 weeks prior to treatment
- Participation in another clinical trial (except observational or survival follow-ups)
- Recent anti-cancer therapy or radiotherapy within specified timeframes
- Use of corticosteroids over 10 mg prednisone equivalent within 2 weeks before treatment (with exceptions)
- Recent anti-tumor or live vaccines within 4 weeks before treatment
- Recent major surgery or severe trauma within 4 weeks before treatment
- Unresolved toxicities from previous anti-tumor treatments above grade 1 (except hair loss)
- Brain metastases
- Active or history of autoimmune diseases except certain stable conditions
- History of immunodeficiency or organ/bone marrow transplants
- Uncontrolled heart conditions or recent heart attack
- Significant urine protein or abnormal coagulation
- Recent severe bleeding or bleeding tendencies
- Active ulcers, wounds, or fractures
- Poorly controlled high blood pressure
- Recent severe infections or active lung inflammation
- History of interstitial lung disease
- Active or recent tuberculosis
- Other cancers within 5 years except low-risk types
- Pregnant or breastfeeding
- Other severe diseases or conditions that might affect participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Until disease progression or intolerable toxicity
Participants receive Fruquintinib, Nab-Paclitaxel, Iparomlimab, and Tuvonralimab until disease progression or intolerable toxicity. After 6 cycles of combination therapy, maintenance treatment with Iparomlimab, Tuvonralimab, and Fruquintinib continues under the same conditions.
1 visit every 3 weeks for treatment administration
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing
Beijing, Beijing Municipality, China
Actively Recruiting
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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