Trifluridine/Tipiracil (TAS-102) With or Without Thalidomide for the Treatment of Metastatic Colorectal Cancer
- Registration Number
- NCT05266820
- Lead Sponsor
- Fujian Cancer Hospital
- 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.
- Detailed Description
In the past decade, the use of targeted drugs has greatly improved the overall survival of patients with mCRC. However, there are currently few effective drugs available clinically. Trifluridine/Tipiracil (TAS-102) is a novel cytotoxic antitumor drug taken orally with minor adverse reactions, consisting of trifluridine and tipyrimidine hydrochloride. Tas-102 has been approved for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and if RAS wild type, an anti-EGFR therapy. Multiple studies have shown that TAS-102 prolongs median OS and PFS in mCRC patients compared with placebo.
Thalidomide is a sedative that was developed in the late 1950s and eventually marketed and prescribed in several countries to pregnant women to alleviate nausea in the late 1950s and early 1960s. The drug, however, caused severe birth defects in more than 10,000 children worldwide and was forced to withdraw from the international market. Further studies found that the S-optical isomer of thalidomide can inhibit neutrophil chemotaxis, produce anti-inflammatory activity, stimulate immune system activation, regulate immunity, anti-angiogenesis, and inhibit the adhesion of cancer cells to stroma, so as to change the microenvironment of the body, and achieve anti-tumor effect.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAS-102+Thalidomide Thalidomide Thalidomide 100mg PO BID+TAS-102 35mg/m2, po, bid, d1-5, d8-12, q4wks TAS-102 TAS-102 TAS-102 35mg/m2, po, bid, d1-5, d8-12, q4wks TAS-102+Thalidomide TAS-102 Thalidomide 100mg PO BID+TAS-102 35mg/m2, po, bid, d1-5, d8-12, q4wks
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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 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.
- Secondary Outcome Measures
Name Time Method Overall survival（OS） From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months OS was defined as the time from the date of randomization to the date of death due to any cause. For subjects who were alive or lost to follow-up by the data analysis cut-off date, survival was censored at the subject's last known survival time.
Incidence of Treatment-Emergent Adverse Events from first dose to within 30 days after the last dose Incidence of Treatment-Emergent Adverse Events were evaluated in accordance with the NCI CTC AE Version 5.0
Trial Locations
- Locations (6)
First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, China
Fuzhou First Hospital affiliated to Fujian Medical University
🇨🇳Fuzhou, China
The Third People's Hospital affiliated to Fujian University of Chinese Medicine
🇨🇳Fuzhou, China
Fujian Medical University Cancer Hospital, Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Provincial people's Hospital
🇨🇳Fuzhou, China
Hospital 900 of the Joint Logistic Support Force of the Chinese People's Liberation Army
🇨🇳Fuzhou, China