Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer

NCT ID: NCT06856187

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed Description

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.

In this study, 119 metastatic colorectal cancer patients who reach CR/PR/SD after 3 months second-line treatment will be randomized to receive sequential TAS-102 +bevacizumab combined with local treatment or continuous treatment of previous second-line therapy. The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, PFS, OS, safety and patient reported outcomes.

Conditions

Metastatic Colorectal Cancer (CRC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Second-line standard therapy sequential TAS-102 and bevacizumab group

Second-line induce therapy followed by TAS-102+bevacizumab maintainance therapy combined with local treatment

Group Type: EXPERIMENTAL

No interventions assigned to this group

Continuous therapy of Standard Treatment Group

Continuous therapy of standard treatment regimen

Group Type: ACTIVE_COMPARATOR

Standard chemotherapy

Intervention Type: DRUG

Standard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab

Interventions

TAS-102+bevacizumab+local treatment

patients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI＋bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment

Intervention Type: DRUG

Standard chemotherapy

Standard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Li Wenhua

Department of Medical Oncology, Fudan University Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenhua Li, Ph.D

Role: CONTACT

whliiris@hotmail.com

8618017317210

Wenhua Li, Ph.D

Role: CONTACT

whliiris@hotmail.com

86 18017317210

Facility Contacts

Jinjia Chang, PhD

Role: primary

86+18017317729

Other Identifiers

FudanU.2411307-13

Identifier Type: -

Identifier Source: org_study_id