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Thalidomide combined with Trifluridine-Tipiracil Hydrochloride Mixture versus Trifluridine-Tipiracil Hydrochloride Mixture in the third-line or higher treatment of advanced colorectal cancer: a randomized, controlled, multicenter phase II clinical study

Thalidomide combined with Trifluridine-Tipiracil Hydrochloride Mixture versus Trifluridine-Tipiracil Hydrochloride Mixture in the third-line or higher treatment of advanced colorectal cancer: a randomized, controlled, multicenter phase II clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051262
Enrollment
Unknown
Registered
2021-09-17
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced colorectal cancer

Interventions

Ttreatment group:Thalidomide
Control group:None

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced colorectal adenocarcinoma confirmed by pathology or clinical diagnosis; 2. Aged 18 to 75 years; 3. There are measurable target lesions; 4. Progression after standard second-line treatment (used irinotecan, oxaliplatin, capecitabine or fluorouracil), oral trifluridine tippiridine treatment; 5. According to the Eastern Cooperative Oncology Group (ECOG) quality of life score of 0 to 2; 6. Expected survival period >= 3 months; 7. Women of childbearing age need a negative pregnancy test; 8. Combined with a small amount of ascites, no obvious symptoms and no clinical intervention; 9. There is no contraindication to chemotherapy in basic examinations such as electrocardiogram, blood, and biochemistry; 10. Patients with known MSI-H but unable to tolerate or afford the cost of immunotherapy and willing to enroll after fully informed.

Exclusion criteria

Exclusion criteria: 1. No reliable contraceptive measures during reproductive period; 2. Patients with gastrointestinal obstruction; 3. Those with a history of thromboembolism, except for thrombosis caused by PICC; 4. Those who are known to be allergic to thalidomide/trifluridine tippiridine tablets; 5. Trifluridine tippiridine tablets have been used in previous treatment.

Design outcomes

Primary

MeasureTime frame
toxic and side effect;overall survival;progression-free survival;objective remission rate;Disease Control Rate;

Countries

China

Contacts

Public ContactGuo Zengqing

Fujian Medical University Cancer Hospital, Fujian Cancer Hospital

gzq_005@126.com+86 13905918836

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026