Actively Recruiting
Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer
Led by LIN YANG · Updated on 2024-12-02
31
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For patients with metastatic gastric cancer, the efficacy of current standard treatments outlined in the guidelines is far from meeting the clinical demand. This study aims to explore the efficacy and safety of trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab as a novel third-line or later-line therapy for metastatic gastric cancer patients.
CONDITIONS
Official Title
Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histopathological confirmed gastric or gastroesophageal junction adenocarcinoma.
- Clinical stage IV according to AJCC 8th edition.
- Previous treatment with at least two systemic therapies.
- May have received or not received immunotherapy.
- May have received or not received anti-VEGFR targeted therapy in the last treatment.
- Age 18 years or older.
- ECOG performance status score of 0 to 2 without deterioration within 2 weeks before first study drug administration.
- Adequate organ function as defined by specific laboratory values for hemoglobin, white blood cells, neutrophils, platelets, creatinine, bilirubin, AST, and ALT.
- Voluntary participation with signed informed consent and good compliance.
You will not qualify if you...
- Histopathological types other than adenocarcinoma such as squamous cell carcinoma, adenosquamous carcinoma, or neuroendocrine carcinoma.
- Known hypersensitivity or prior treatment with trifluridine/tipiracil or its components.
- Known hypersensitivity to any component of bevacizumab.
- Use of systemic corticosteroids over 10 mg/day prednisone or equivalent for more than 7 days within 14 days before enrollment, with some exceptions.
- Receipt of live vaccines or systemic immunostimulants within 28 days before enrollment.
- Past or current interstitial pneumonia unless non-active and not requiring hormone therapy.
- Past or current autoimmune diseases excluding some specified exceptions.
- History of severe allergic reactions to antibody medications or significant allergies.
- History of bone marrow or organ transplantation.
- Conditions affecting drug intake or absorption such as inability to swallow or intestinal obstruction.
- Uncontrolled recurrent bleeding or major surgery within 4 weeks before treatment.
- Concurrent malignancy within the past 5 years except certain adequately treated cancers.
- History of gastrointestinal perforation, fistula, inflammatory bowel disease, or extensive bowel resection.
- Severe cardiac insufficiency or recent serious heart events.
- Uncontrolled hypertension or diabetes.
- History of ventricular tachycardia or significant ECG abnormalities.
- Active infections including hepatitis B or C, HIV, syphilis, pulmonary tuberculosis, or recent pulmonary embolism.
- Severe pulmonary disease requiring oxygen therapy.
- Active infections requiring intravenous treatment within 2 weeks before study drug.
- History of substance abuse.
- Pregnancy or lactation.
- Fertile individuals unwilling to use effective contraception.
- Any other conditions judged by investigators to make participation unsafe or affect study results.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
L
Lin Yang
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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