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

ConditionGastric Cancer Adenocarcinoma Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLIN YANG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: trifluridine/tipiracil, bevacizumab, camrelizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time frame
2 years

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
2 years
2

12-week PFS rate

Time frame
12 weeks after the last patient was enrolled
3

6-month PFS rate

Time frame
6 months after the last patient was enrolled.
4

Disease Control Rate (DCR)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LIN YANG

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov
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