Fact CheckerSign in

NCT06856187RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
119 (estimated)
First submitted
26 Feb 2025
Start date
28 Feb 2025
Primary completion date
30 Jun 2026
Lead sponsor
Fudan University
NCT number
NCT06856187

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 119
  • From 28 Feb 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Allergy to the investigational drug and/or its excipients;
  • 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;

Other illness

  • Inability to swallow pills, presence of malabsorption syndrome or any condition affecting gastrointestinal absorption;

Other

  • Pregnant or lactating women;
  • The investigator assessed that it is not appropriate to participate in the study.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.