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Gastric Cancer Adenocarcinoma MetastaticPhase 2NCT06711471

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

A Phase 2 study testing trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab in people with Gastric Cancer Adenocarcinoma Metastatic, run by LIN YANG at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer Adenocarcinoma Metastatic
What is being tested?
trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
14 Nov 2024to 13 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • With a full understanding of the study, each participant volunteered to participate in this study and signed the informed consent (ICF) with good compliance and follow-up.

Who cannot join

  • 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.
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  • 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.
  • Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) and diabetes (fasting blood glucose > 8.9 mmol/l).
  • History of ventricular tachycardia or torsades de pointes. Any resting ECG with significant clinical abnormalities in rhythm, conduction, or morphology, such as QTc > 450 msec for males, QTc > 470 msec for females, complete left bundle branch block, or third-degree atrioventricular block.
  • Active hepatitis B (must meet both HBsAg positive and HBV DNA ≥ 2000 IU/ml, or ≥ 104 copies, excluding hepatitis due to drugs or other causes), active hepatitis C (must meet both anti-HCV antibody positive and HCV RNA positive), syphilis (further testing for syphilis titer is required for those with positive syphilis antibodies), or human immunodeficiency virus (HIV) infection.
  • Pulmonary embolism or deep vein thrombosis occurring within 3 months before the first administration of the study drug (excluding thrombosis caused by catheters such as port, PICC, etc.).
  • Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or those who have received anti-tuberculosis treatment within 1 year before the first dose.
  • Severe primary pulmonary disease, currently requiring continuous oxygen therapy for clinical active interstitial lung disease (ILD) or a history of pneumonia.
  • Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infection requiring intravenous anti-infective treatment within 2 weeks before the first administration of the study drug.
  • Known history of substance abuse or drug addiction.
  • Pregnant or lactating women.
  • Fertile but unwilling to use effective contraceptive measures.
  • Any other diseases, metabolic disorders, or laboratory test abnormalities that the investigator has reason to suspect would make the patient unsuitable for treatment with the study drug, would affect the interpretation of the study results, or would place the patient at high risk.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Yang contact

13611267380

linyangcicams@126.com

China1 site, 1 recruiting

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

    Beijing, Beijing Municipality, 100021

    Lin Yang, 13611267380, linyangcicams@126.com

    Lin Yang

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This study is an explorative prospective phase II clinical study. The study recruits patients with advanced gastric/gastroesophageal junction adenocarcinoma who have experienced disease progression after at least two lines of systemic therapy.

Participants must undergo screening tests within 28 days before treatment to determine their eligibility for the study. Patients who meet the inclusion criteria will receive treatment with trifluridine and tipiracil combined with bevacizumab and camrelizumab, with a treatment cycle of 14 days until disease progression, death, intolerable toxicity, or other criteria for terminating study treatment as specified in the protocol (whichever occurs first).

Tumor assessment will be conducted according to the RECIST 1.1 criteria. It will be performed by the researcher or designated research staff every 3 cycles after the start of treatment, until disease progression, death, the initiation of other anti-tumor treatments, or withdrawal of informed consent. Safety follow-up will be conducted after the last dose to monitor the resolution of adverse events. After treatment termination, participants will be followed up for survival every 90 days until death or loss of follow-up.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumabDrug

    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).

Study groups in NCT06711471
Study groupRoleWhat they receive
trifluridine/tipiracil, bevacizumab, camrelizumabExperimentalTAS-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.
Receives: Drug: trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Measured: 2 years

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    Measured: 2 years

  2. 12-week PFS rate

    Measured: 12 weeks after the last patient was enrolled

  3. 6-month PFS rate

    Measured: 6 months after the last patient was enrolled.

  4. Disease Control Rate (DCR)

    Measured: 2 years

  5. Overall Survival (OS)

    Measured: 2 years

  6. Treatment-Related Adverse Events (TRAEs)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start14 Nov 2024
  3. Primary completion13 Nov 2026 (estimated)
  4. Study completion13 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711471
Sponsor's protocol ID
NCC4916
Status last verified
Nov 2024
First submitted
26 Nov 2024
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab in people with Gastric Cancer Adenocarcinoma Metastatic, run by LIN YANG at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lin Yang (13611267380, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06711471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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