Combining TAS-102 and Bevacizumab with Local Treatment for 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

This study is testing a new combination of medications and local treatment for patients with advanced colorectal cancer who didn't get better with their first treatment to see if it works better than the usual second-line therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, bevacizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06856187 on ClinicalTrials.gov

What this trial studies

This phase II clinical study evaluates the efficacy and safety of a sequential treatment approach using TAS-102 and bevacizumab combined with local treatment in patients with advanced colorectal cancer who have not responded to first-line therapy. A total of 119 patients will be randomized to receive either the new combination treatment or continue with standard second-line therapy. The primary goal is to assess the time to treatment failure, while secondary goals include overall response rate, disease control rate, progression-free survival, overall survival, safety, and patient-reported outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable colorectal adenocarcinoma who have failed first-line therapy and have measurable lesions.

Not a fit: Patients with prior treatment using TAS-102 or those with significant unresolved toxicity from previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in advanced colorectal cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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:

  1. Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
  2. Known brain and/or leptomeningeal metastases;
  3. Active infection or fever of unknown origin \> 38.5 ° C ;
  4. 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;
  5. Known inherited or acquired bleeding (e.g., coagulopathy)
  6. 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;
  7. Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;
  8. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (NYHA Class III or IV) within the last 12 months;
  9. Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;
  10. 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Wenhua Li, Ph.D

Conditions: Metastatic Colorectal Cancer, Colorectal cancer, TAS-102, second-line therapy, maintainance therapy