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Clinical Trials in China / NCT07085169
Recruiting Phase 2

Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

NCT07085169 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Phase 2
Started
2025-08-01
Last updated
2025-07-25

Condition(s) studied

Colo-rectal CancerThird-line and Beyond TherapyTAS 102Bevacizumab

Investigational drug(s) / intervention(s)

Trifluridine/tipiracil (TAS-102) plus bevacizumabAll Trifluridine/Tipiracil trials (44) →All Bevacizumab trials (435) →

Trifluridine/tipiracil (TAS-102) plus bevacizumab: Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.

Study summary

This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. age over 60 years old, male and female 2. histologically confirmed adenocarcinoma of the colon or rectum 3. patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen 4. with or without measurable lesions 5. ECOG 0 to 2, expected survival time over 3 months 6. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. 7. Signed informed consent and willing to follow the study protocol Exclusion Criteria: 1. symptomatic metastases of central nervous system 2. other primary malignancies 3. uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease 4. organ functions that cannot tolerate study treatment 5. bowel obstruction or other conditions affecting oral administration 6. allergic to study medication 7. other conditions that patients are unsuitable for this study assessed by the investigators

Primary outcome measure(s)

  • 6-month progression-free survival rate — 6 months
    Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.

Trial sites (2)

FacilityCityRegionStatus
SanMing First Hospital Sanming China Recruiting
Ruijin Hospital Shanghai China Recruiting

More Ruijin Hospital trials in China

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A Single Cycle of Intravenous Immunoglobulin as Adjuvant to Rituximab in Patients With Pemphigus: A Retrospective Cohort Study at a Tertiary Referral Center Active, not recruiting
Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer Recruiting

Other trials for the same condition

TAS-102 Plus Radiotherapy in Elderly ESCC Starting soon
FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases. Starting soon
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma Recruiting
QL1706 in Combination With Bevacizumab and RALOX HAIC for Hepatocellular Carcinoma With Vp3/4 PVTT Recruiting
Impact of Pre- and Post-operative Serum Metabolome Dynamics in Colorectal Resection Outcomes Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07085169 on ClinicalTrials.gov ↗ ← All trials in China