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

NCT06856187 | Recruiting Phase 2

• 1 other identifier: FudanU.2411307-13
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer (CRC)

Keywords

Colorectal cancer; TAS-102; second-line therapy; maintainance therapy

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF)

  TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.

  up to approximately 2 years.

Secondary Outcomes (7)

• Objective response rate (ORR)

  up to approximately 2 years.

• Disease control rate (DCR)

  up to approximately 2 years.

• Progression-free survival (PFS)

  up to approximately 2 years.

• Overall survival（OS）

  up to approximately 2 years.

• Adverse Events

  up to approximately 2 years.

Study Arms (2)

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

EXPERIMENTAL

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

Continuous therapy of Standard Treatment Group

ACTIVE COMPARATOR

Continuous therapy of standard treatment regimen

Drug: Standard chemotherapy

Interventions

TAS-102+bevacizumab+local treatment DRUG

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

Standard chemotherapy DRUG

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

Continuous therapy of Standard Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Wenhua Li, Ph.D

CONTACT

8618017317210; whliiris@hotmail.com

Wenhua Li, Ph.D

CONTACT

86 18017317210; whliiris@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)