Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard chemotherapy | Drug | Chemotherapy | ALIAS |
| TAS-102+bevacizumab+local treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Second-line standard therapy sequential TAS-102 and bevacizumab group
- description
- Second-line induce therapy followed by TAS-102+bevacizumab maintainance therapy combined with local treatment
- type
- ACTIVE_COMPARATOR
- label
- Continuous therapy of Standard Treatment Group
- description
- Continuous therapy of standard treatment regimen
- interventionNames
- Drug: Standard chemotherapy
Primary outcomes (1)
- measure
- Time to treatment failure (TTF)
- timeFrame
- up to approximately 2 years.
- description
- TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available