Actively Recruiting
Phase II Study of Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As a Third-line or Later-line Therapy for Patients with Metastatic Gastric Cancer
Led by LIN YANG · Updated on 2024-12-02
31
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment combination for patients with metastatic gastric or gastroesophageal junction adenocarcinoma who have already undergone at least two previous systemic therapies. The goal is to explore how well trifluridine/tipiracil (TAS-102), bevacizumab, and camrelizumab work together as a third-line or later therapy, addressing the need for more effective options in advanced gastric cancer. This phase II clinical trial aims to assess both the safety and effectiveness of this regimen. During the study, participants will receive trifluridine/tipiracil orally twice daily on days 1 to 5, bevacizumab and camrelizumab as intravenous infusions on day 1, with each treatment cycle lasting 14 days. Treatment continues until disease progression, unacceptable side effects, death, or other protocol-defined reasons for stopping. Tumor response will be evaluated every three cycles using RECIST 1.1 criteria to monitor changes in cancer status. Participants will undergo various screening tests before starting treatment to confirm eligibility, including laboratory tests to ensure adequate organ function. Throughout the study, safety follow-up will monitor adverse events after the last dose. After treatment ends, patients will be followed every 90 days to track survival until death or loss to follow-up. The main outcome measured is progression-free survival over two years, along with other indicators such as response rates, overall survival, and treatment-related side effects.
CONDITIONS
Brief 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 histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Clinical stage IV disease according to AJCC 8th edition.
- Received at least two prior systemic therapies.
- May or may not have received immunotherapy.
- May or may not have received anti-VEGFR targeted therapy previously.
- Age 18 years or older.
- ECOG performance status of 0 to 2 without recent deterioration within 2 weeks before treatment.
- Adequate organ function based on specific laboratory values including hemoglobin, white blood cells, neutrophils, platelets, creatinine, bilirubin, and liver enzymes.
- Voluntary informed consent with good compliance and follow-up ability.
You will not qualify if you...
- Histopathological types other than adenocarcinoma such as squamous cell carcinoma or neuroendocrine carcinoma.
- Known allergy to trifluridine/tipiracil, bevacizumab, or their components.
- Need for systemic corticosteroids or immunosuppressive therapy within the specified recent time frames.
- Recent live vaccine or systemic immunostimulant use.
- Active or recent interstitial pneumonia or autoimmune diseases except some stable conditions.
- History of severe allergies to antibody medications or other substances.
- History of bone marrow or organ transplantation.
- Difficulty swallowing or intestinal obstruction.
- Uncontrolled bleeding or recent major surgery.
- Other active or recent malignancies within 5 years, with some exceptions.
- History of gastrointestinal perforation, fistula, or inflammatory bowel diseases.
- Severe heart conditions or uncontrolled hypertension and diabetes.
- Significant ECG abnormalities or arrhythmias.
- Active infections including hepatitis B, C, HIV, tuberculosis, or others requiring treatment.
- Recent blood clots.
- Substance abuse history.
- Pregnancy or breastfeeding.
- Fertile patients unwilling to use contraception.
- Any other condition judged unsafe or interfering with study participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression, death, or intolerance
Participants receive trifluridine/tipiracil combined with bevacizumab and camrelizumab in 14-day cycles until disease progression, intolerable toxicity, death, or other criteria for stopping treatment.
Repeated visits every 14 days for treatment administration
Duration - Survival follow-up every 90 days until death or loss of follow-up
After treatment ends, participants are followed up for safety and survival monitoring.
Follow-up visits every 3 months
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
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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