Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer

NCT06711471 | Recruiting Phase 2

• 1 other identifier: NCC4916
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer Adenocarcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  2 years

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  2 years

• 12-week PFS rate

  12 weeks after the last patient was enrolled

• 6-month PFS rate

  6 months after the last patient was enrolled.

• Disease Control Rate (DCR)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

trifluridine/tipiracil, bevacizumab, camrelizumab

EXPERIMENTAL

TAS-102 35mg/m² twice daily, orally on Days 1-5; Bevacizumab 5mg/kg intravenous infusion on Day 1; Camrelizumab 200mg intravenous infusion on Day 1; Repeat every 14 days.

Drug: trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab

Interventions

trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab DRUG

Patients enrolled in this study will receive trifluridine/tipiracil in combination with bevacizumab and camrelizumab, with a treatment cycle of 14 days, until disease progression, death, intolerable toxicity, or other criteria for discontinuation of study treatment as specified in the protocol (whichever occurs first).

trifluridine/tipiracil, bevacizumab, camrelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
• The clinical stage was IV, according to AJCC 8th edition.
• Patients had received at least two systematic therapies.
• Patients had received or not received immunotherapy.
• The patients received or did not receive anti-VEFGR targeted therapy in the last treatment (e.g., Bevacizumab, Ramucirumab, anti-VEGFR TKIs, etc.).
• Age ≥18.
• ECOG physical status score is 0-2 without deterioration within 2 weeks before the first administration of the investigational drug.
• Adequate organ function according to the following laboratory test values:
• Hemoglobin value ≥90g/L.
• White blood cell count ≥3.5\*109/L.
• Absolute neutrophil count ≥1.5\*109/L.
• Platelet count ≥100\*109/L.
• Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.
• Total serum bilirubin ≤1.5 upper normal limit (ULN).
• Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 upper limit of normal value (ULN).

You may not qualify if:

• Histopathological types other than adenocarcinoma include squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, etc.
• Known hypersensitivity or previous treatment with trifluridine/tipiracil or any of its components or excipients.
• Known hypersensitivity to any component or excipients of bevacizumab.
• Requirement for systemic corticosteroids (\>10mg/day of prednisone or equivalent other corticosteroids, for a continuous treatment of ≥7 days) or immunosuppressive therapy within 14 days before enrollment; excluding inhaled or topical steroid use, or hormone therapy for adrenal insufficiency at physiological replacement doses; short-term (≤7 days) corticosteroids are allowed for prevention (e.g., contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity caused by contact allergens).
• Receipt of a live vaccine (including attenuated live vaccines) or systemic immunostimulants (including but not limited to interferon or interleukin-2) within 28 days before enrollment.
• Past or current interstitial pneumonia disease, except for those non-active and not requiring hormone therapy determined by the investigator.
• Past or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophyseal inflammation, uveitis, autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. except for type I diabetes, hormonally replaced euthyroidism (including autoimmune thyroid disease causing hypothyroidism), psoriasis or vitiligo not requiring systemic treatment.
• History of hypersensitivity, severe allergic reactions, or intolerance to antibody medications; history of significant allergies to drugs, foods, or other substances (e.g., severe allergic reactions, immunologically mediated hepatotoxicity, immunologically mediated thrombocytopenia, or anemia).
• History of allogeneic bone marrow or organ transplantation.
• Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption.
• Recurrent bleeding that cannot be controlled (as judged by the investigator to be at risk for major gastrointestinal bleeding, etc.).
• Major surgery was performed within 4 weeks before the first study drug treatment (biopsy procedures excepted).
• Concurrent malignancy within the past 5 years, except for those adequately treated cervical carcinoma in situ, localized squamous cell carcinoma of the skin, basal cell carcinoma, asymptomatic prostate cancer, ductal carcinoma in situ of the breast, well-differentiated thyroid cancer, or urinary tract epithelial cancer \< T1, adequately treated lung carcinoma in situ, or other malignancies considered cured.
• History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), inflammatory bowel disease, or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
• Any severe cardiac insufficiency, including left ventricular ejection fraction (LVEF) \< 50%, congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0 or New York Heart Association grade ≥ 2), myocardial infarction, severe/unstable angina, stroke, or transient ischemic attack (TIA) within 6 months before enrollment.

Sponsors & Collaborators

• LIN YANG: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

Trifluridine; tipiracil; trifluridine tipiracil drug combination; Bevacizumab; camrelizumab

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lin Yang

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yang

CONTACT

13611267380; linyangcicams@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2027
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)