Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
Recruiting
Phase 2Interventional Study
Metastatic Colorectal Cancer (CRC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
119 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 Performanc…
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.
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