Status:
ACTIVE_NOT_RECRUITING
A Study of Trifluridine/Tipiracil Combined With Anlotinib as Second-line Treatment for Recurrent and Metastatic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Esophageal Squamous Cell Carcinoma (ESCC)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Esophageal squamous cell carcinoma (ESCC) is one of the malignant tumors with a high incidence worldwide, especially remaining persistently high in Asian regions. Despite advancements in early diagnos...
Eligibility Criteria
Inclusion
- Patients with pathologically confirmed esophageal squamous cell carcinoma.
- Clinical stage IIIB-C or IV according to the 8th edition of AJCC.
- Having at least one measurable or evaluable lesion.
- ECOG performance status score of 0-2.
- Failed first-line standard treatment regimens.
- Age ≥ 18 years.
- Normal function of major organs.
- Female subjects of childbearing age must undergo a pregnancy test within 3 days before the first dose with a negative result, and adopt effective contraceptive measures during the study period.
Exclusion
- Patients with other malignant tumors requiring treatment.
- Patients with severe diseases of major organs such as heart, liver, and kidney.
- Patients who have previously received treatment with anti-angiogenic monoclonal antibodies or small-molecule tyrosine kinase inhibitors.
- Patients with an expected survival period of \< 3 months.
- Patients who have previously used fluoropyrimidine drugs (such as 5-FU, capecitabine, etc.).
- Patients with Uncontrolled active infections (such as HIV, HCV, HBV, etc.).
- Pregnant or lactating women.
- Other circumstances deemed unsuitable for enrollment by the researcher.
Key Trial Info
Start Date :
August 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07142421
Start Date
August 6 2025
End Date
December 30 2027
Last Update
August 26 2025
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003