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Tests treatment safety and results for Gastric Cancer Adenocarcinoma Metastatic
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
ClinicalTrials.gov ID: NCT07392346
What this study is testing
What is Fruquintinib?
Fruquintinib is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for gastric cancer adenocarcinoma metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years
- Pathologically or cytologically confirmed diagnosis of gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
- Failure of first-line treatment with PD-1/PD-L1 inhibitors
- With measurable lesions according to RECIST 1.1 criteria.
- ECOG performance status of 0-1
You likely can't join if
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of study medication.
- Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage.
- Hypersensitivity to any component of monoclonal antibodies, fruquintinib, or albumin-bound paclitaxel.
- Receipt of any of the following treatments:
- Severe adverse reactions to prior immunotherapy.
- Prior treatment with CTLA4 inhibitors.
See the full eligibility criteria
Who can join
- ≥ 18 years
- Pathologically or cytologically confirmed diagnosis of gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
- Failure of first-line treatment with PD-1/PD-L1 inhibitors
- With measurable lesions according to RECIST 1.1 criteria.
- ECOG performance status of 0-1
- Expected survival ≥3 months;
- Major organ functions meet the following requirements :
- Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L) (no growth factors used within 14 days).
- Platelet count (PLT) ≥ 100,000/mm³ (100 × 10⁹/L) (no correction therapy used within 7 days).
- Hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no correction therapy used within 7 days).
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN).
- Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels ≤ 2.5 × upper limit of normal (ULN); ≤ 5 × upper limit of normal (ULN) for patients with liver metastases.
- Urinalysis is normal, or urine protein \< (++), or 24-hour urine protein level \< 1.0 g.
- Normal coagulation function, with no history of active bleeding or thrombotic diseases:
- International normalized ratio (INR) ≤ 1.5 × ULN.
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Prothrombin time (PT) ≤ 1.5 × ULN.
- For patients with potential fertility, the following requirements must be met:
- Adopt a medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after the completion of study treatment.
- Serum human chorionic gonadotropin (β-HCG) test must be negative within 72 hours prior to study enrollment.
- Must not be breastfeeding.
- Patients must have provided written informed consent, and be willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other trial procedures.
What rules you out
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of study medication.
- Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage.
- Hypersensitivity to any component of monoclonal antibodies, fruquintinib, or albumin-bound paclitaxel.
- Receipt of any of the following treatments:
- Severe adverse reactions to prior immunotherapy.
- Prior treatment with CTLA4 inhibitors.
- Any study medication within 4 weeks prior to the first dose of study medication.
- Concurrent enrollment in another clinical study (excluding observational studies or survival follow-ups of treatment studies).
- Last dose of anti-cancer therapy ≤ 3 weeks prior to the first study medication, or fixed-field palliative radiotherapy ≤ 2 weeks prior to study intervention.
- Corticosteroid use (\>10 mg prednisone equivalent/day) within 2 weeks prior to study medication; the investigator may decide on eligibility in special cases. Inhaled/topical steroids and adrenal replacement at \>10...
- Anti-tumor vaccines or live vaccines within 4 weeks prior to study medication.
- Major surgery or severe trauma within 4 weeks prior to study medication.
- Previous anti-tumor treatment toxicities not recovered to ≤ CTCAE Grade 1 (excluding alopecia) or the specified inclusion/exclusion criteria levels.
- Central nervous system metastases.
- History of active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) or a history of such diseases (excluding vitiligo, or...
- Immunodeficiency history (including HIV-positive status, acquired/congenital immunodeficiency, organ transplantation, or allogeneic bone marrow transplantation).
- Inadequately controlled cardiovascular symptoms/diseases, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant...
- Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein \>1.0 g.
- Abnormal coagulation (INR \>1.5×ULN or PT \>ULN+4s), with bleeding tendency or thrombolytic/anticoagulant therapy (small-dose low-molecular-weight heparin or oral aspirin for prophylaxis permitted during the trial).
- Significant clinical bleeding or definite bleeding tendency within 3 months (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis). If baseline occult blood in stool is positive, re-testing is allowed...
- Active ulcers, unhealed wounds, or fractures.
- Hypertension inadequately controlled by anti-hypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg).
- Severe infection (CTCAE \>Grade 2) within 4 weeks prior to study medication (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization); baseline chest imaging showing active pulmonary...
- History of interstitial lung disease (excluding radiation pneumonitis or non-infectious pneumonitis not treated with steroids).
- Active tuberculosis (confirmed by history/CT) or history of active tuberculosis within 1 year prior to enrollment, or untreated active tuberculosis more than 1 year prior to enrollment.
- History of any other malignant tumor within 5 years prior to study medication (excluding low-risk tumors with \>90% 5-year survival rate, e.g., adequately treated basal cell/squamous cell skin cancer or cervical...
- Pregnant or breastfeeding women.
- Other factors (e.g., concurrent severe diseases including mental illness, severely abnormal lab values, family/social factors) that may lead to forced withdrawal from the study, as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.