TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer

NCT06293014 | Recruiting Phase 2

• 1 other identifier: QLMA-CRC-IIT-001
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.

Conditions

Colorectal Cancer

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 (8)

• Objective response rate (ORR)

  up to approximately 2 years.

• Disease control rate (DCR)

  up to approximately 2 years.

• Duration of Response (DoR)

  up to approximately 2 years.

• Progression-free survival (PFS)

  up to approximately 2 years.

• Overall survival（OS）

  up to approximately 2 years.

Study Arms (2)

second-line maintenance treatment group

EXPERIMENTAL

TAS-102 combined with bevacizumab

Drug: TAS-102+bevacizumab

second-line continuous treatment group

ACTIVE COMPARATOR

Standard chemotherapy (FOLFOX，FOLFIRI or CAPEOX) combined with bevacizumab

Drug: Standard chemotherapy+bevacizumab

Interventions

TAS-102+bevacizumab DRUG

TAS-102 35mg/m2, PO, D1-5, repeated every 14 days; Bevacizumab 5mg/kg, IV, D1, repeated every 14 days; Q4w.

Also known as: Trifluridine and Tipiracil Hydrochloride Tablets; bevacizumab

second-line maintenance treatment group

Standard chemotherapy+bevacizumab DRUG

Standard chemotherapy (chemotherapy regimen based on investigator's choice, including FOLFIRI, FOLFOX, or CAPEOX); Bevacizumab

Also known as: Bevacizumab

second-line continuous treatment group

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
• Age ≥18 years old;
• Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
• After receiving 12 weeks of standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab second-line induction therapy, the patients are confirmed as CR, PR, or SD according to RECIST 1.1 criteria;
• The interval between the last second-line induction therapy and randomization is not more than 6 weeks;
• At least one measurable lesion according to RECIST 1.1 criteria;
• ECOG Performance Status 0-2;
• Estimated life expectancy ≥12 weeks;
• Adequate major organ function (no medication for blood component, cell growth factor correction therapy is allowed within 14 days before randomization);
• Women of child-bearing potential must agree to abstain from sex (heterosexual intercourse) or use a reliable, effective method of contraception from the time they provide informed consent until at least 90 days after the last dose of study drug is administered. Serum or urine HCG test must be negative. And must be non-lactating;
• Male participants whose partner is a woman of child-bearing potential must agree to abstain from sex or use a reliable,effective method of contraception from the time they sign an informed consent form until at least 90 days after the last dose of study drug is administered. Male subjects also have to agree not to donate sperm during the same period.

You may not qualify if:

• Any CTCAE grade 1 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
• Known history or evidence of interstitial lung disease or active noninfectious pneumonia;
• 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;
• Have bleeding tendency and high risk of bleeding;
• 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);
• 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;
• 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 tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption;
• Patients with congenital or acquired immune deficiency (such as HIV infection);
• Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV virus copy number \> upper limit of normal);
• Known brain and/or leptomeningeal metastases. All subjects should receive brain CT/MRI to exclude brain metastases;
• Active infection or fever of unknown origin \> 38.5 ° C within 2 weeks before the first dose (tumor-related fever, as judged by the investigator, was eligible);
• Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;
• Have poorly controlled cardiac clinical symptoms or disease；

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Trifluridine; Bevacizumab

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

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ying Liu, Dr

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Liu, Dr

CONTACT

13783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: March 5, 2024
• Study Start: February 23, 2024
• Primary Completion: October 15, 2025
• Study Completion (Estimated): November 28, 2026
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)