Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
Recruiting now · Phase 2
Conditions studied: Metastatic Colorectal Cancer (CRC)
In brief
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.
Key facts
- Study ID
- NCT06856187
- Run by
- Fudan University
- People needed
- 119
- Starts
- 2025-02-28
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2025-08-06
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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