Actively Recruiting
Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer
Led by Dai, Guanghai · Updated on 2026-02-11
68
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immunotherapy has established the new standard for first-line treatment of advanced or metastatic gastric cancer. However, current second-line options-predominantly consisting of targeted therapy plus chemotherapy or chemotherapy alone-confer only modest clinical benefit. Notably, pivotal phase III second-line trials (REGARD, RAINBOW, RAINBOW-Asia, FRUTIGA) exclusively enrolled patients who progressed on chemotherapy regimens; thus, high-quality evidence guiding second-line treatment specifically for immunotherapy-refractory patients remains scarce, representing a significant unmet medical need. Anti-angiogenic agents have demonstrated capacity to ameliorate the hypoxic, immunosuppressive tumor microenvironment while exerting synergistic anti-tumor effects when combined with immune checkpoint inhibitors. Exploratory studies evaluating immunotherapy combined with anti-angiogenic therapy plus chemotherapy in advanced gastric cancer patients after first-line failure have yielded encouraging efficacy signals (NCT03966118, NCT04982276), with objective response rates of 30-40% and median progression-free survival approaching 6 months. Based on this, the investigators aim to evaluate the efficacy and safety profile of fruquintinib combined with nab-paclitaxel and Iparomlimab and Tuvonralimab Injection (a novel bispecific antibody) as second-line treatment for patients with advanced gastric cancer who have experienced disease progression during or after first-line immunotherapy-containing regimens.
CONDITIONS
Official 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
- Pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer
- Disease progression after first-line treatment with PD-1/PD-L1 inhibitors
- Presence of measurable tumors according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate major organ function including specific blood counts and liver/kidney function within defined limits
- Normal or acceptable urine protein levels
- Normal blood clotting function without active bleeding or thrombotic diseases
- For patients who can conceive, use of effective contraception during treatment and for 3 months after
- Negative pregnancy test within 72 hours prior to enrollment
- Not breastfeeding
- Willing and able to provide informed consent and comply with study procedures
You will not qualify if you...
- History of gastrointestinal perforation or fistula within 6 months before starting study treatment
- Uncontrolled fluid build-up in chest, heart sac, or abdomen requiring 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 any study medication within 4 weeks before starting study treatment
- Participation in another clinical study (except observational or survival follow-ups)
- Recent anti-cancer therapy within 3 weeks or palliative radiotherapy within 2 weeks before study treatment
- Use of corticosteroids over 10 mg prednisone equivalent per day within 2 weeks before treatment (with some exceptions)
- Receipt of anti-tumor or live vaccines within 4 weeks prior to study treatment
- Major surgery or severe trauma within 4 weeks before study treatment
- Unresolved toxicities from prior cancer treatments worse than CTCAE Grade 1 (except hair loss)
- Presence of central nervous system metastases
- History or presence of active autoimmune diseases (with some exceptions)
- Immunodeficiency conditions including HIV or organ/bone marrow transplant
- Poorly controlled heart diseases or recent serious heart events
- High urine protein levels beyond defined limits
- Abnormal blood clotting with bleeding risks or ongoing anticoagulant therapy (with some allowances)
- Recent significant bleeding or bleeding tendencies
- Active ulcers, unhealed wounds, or fractures
- Poorly controlled high blood pressure
- Severe infections within 4 weeks before treatment
- History of interstitial lung disease (except certain types)
- Active or recent tuberculosis
- History of other cancers within 5 years except low-risk types
- Pregnant or breastfeeding women
- Other severe diseases or conditions that might lead to withdrawal, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here