RecruitingPhase 2NCT06856187

Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer

A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer


Sponsor

Fudan University

Enrollment

119 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.


Eligibility

Inclusion Criteria7

  • Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
  • Patients who have failed first-line standard therapy and are intended to receive second-line standard therapy;
  • At least one measurable lesion according to RECIST 1.1 criteria;
  • ECOG Performance Status 0-1;
  • Estimated life expectancy ≥3months;
  • Adequate major organ function;
  • Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.

Exclusion Criteria19

  • Allergy to the investigational drug and/or its excipients;
  • Pregnant or lactating women;
  • Prior treatment with TAS-102;
  • Any CTCAE grade 2 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
  • Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
  • Serious illness, including but not limited to the following:
  • Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
  • Known brain and/or leptomeningeal metastases;
  • Active infection or fever of unknown origin \> 38.5 ° C ;
  • Poorly controlled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;
  • Known inherited or acquired bleeding (e.g., coagulopathy)
  • Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;
  • Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;
  • Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (NYHA Class III or IV) within the last 12 months;
  • Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;
  • There are serious psychological or psychiatric abnormalities that affect the compliance of patients to participate in this clinical study.
  • Has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period;
  • Inability to swallow pills, presence of malabsorption syndrome or any condition affecting gastrointestinal absorption;
  • The investigator assessed that it is not appropriate to participate in the study.

Interventions

DRUGTAS-102+bevacizumab+local treatment

patients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI+bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment

DRUGStandard chemotherapy

Standard therapy:FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06856187


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