Trifluridine/Tipiracil (TAS-102) With or Without Thalidomide for the Treatment of Metastatic Colorectal Cancer

NCT05266820 | Unknown Phase 2 DMC

• 1 other identifier: TACTIC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

Thalidomide has both anti-angiogenesis and antiemetic effects, and its combined use with TAS-102 may reduce the gastrointestinal reactions associated with TAS-102, while enhancing antitumor efficacy and reducing the side effects of chemotherapy, and its cost is significantly lower than that of bevacizumab, which has higher pharmacoeconomics and greater clinical research application value.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (2)

• Overall survival（OS）

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

• Incidence of Treatment-Emergent Adverse Events

  from first dose to within 30 days after the last dose

Study Arms (2)

TAS-102+Thalidomide

EXPERIMENTAL

Thalidomide 100mg PO BID+TAS-102 35mg/m2, po, bid, d1-5, d8-12, q4wks

Drug: Thalidomide; Drug: TAS-102

TAS-102

ACTIVE COMPARATOR

TAS-102 35mg/m2, po, bid, d1-5, d8-12, q4wks

Drug: TAS-102

Interventions

Thalidomide DRUG

For the experimental group, the intervention was thalidomide（100mg PO Bid)

Also known as: Thalidomide Tablets produced by Changzhou Pharmaceutical Factory Co. LTD

TAS-102+Thalidomide

TAS-102 DRUG

TAS-102

TAS-102; TAS-102+Thalidomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• With arterial or venous thrombosis or embolic events such as myocardial infarction, cerebral thrombosis, intracerebral hemorrhage, deep venous thrombosis or pulmonary embolism within 6 months before the start of the study.
• Evidence or history of any bleeding diathesis, irrespective of severity. Any hemorrhage or bleeding event ≥ grade 3 (adverse events per CTCAE v5.0) within 4 weeks prior to the start of treatment.
• Peripheral neuropathy \> grade 1 (adverse events per CTCAE v5.0).
• History of uncontrolled or medicated heart disease.
• Seizure disorder requiring medication.
• Known history of human immunodeficiency virus (HIV) infection.
• Patients with an active infection.
• Other uncontrolled concurrent diseases determined by the researchers as not meeting the study conditions.
• Patients with ascites and pleural effusion with clinical symptoms requiring treatment.
• Known allergy to any of the study drug ingredients.
• Unable to swallow oral medication.
• Prior exposure to TAS-102 or thalidomide.
• Patients who have brain metastases.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (6)

Fujian Medical University Cancer Hospital, Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

First Affiliated Hospital of Fujian Medical University

Fuzhou, China

NOT YET RECRUITING

Fujian Provincial people's Hospital

Fuzhou, China

NOT YET RECRUITING

Fuzhou First Hospital affiliated to Fujian Medical University

Fuzhou, China

NOT YET RECRUITING

Hospital 900 of the Joint Logistic Support Force of the Chinese People's Liberation Army

Fuzhou, China

NOT YET RECRUITING

The Third People's Hospital affiliated to Fujian University of Chinese Medicine

Fuzhou, China

NOT YET RECRUITING

Related Publications (16)

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• 中国临床肿瘤学会（CSCO）.抗肿瘤治疗相关恶心呕吐预防和治疗指南（M）.（2019.V1.0）

  BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Thalidomide; trifluridine tipiracil drug combination

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Zengqing Guo

CONTACT

+86 13860603879; gzq_005@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: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 4, 2022
• Study Start: October 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2023
• Last Updated: March 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)