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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Not Yet Recruiting PHASE1, PHASE2 INTERVENTIONAL NCT04310774

CCRT Followed by Tegafur, Gimeracil and Oteracil Potassium in Cervical Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy in patients with locally advanced cervical cancer.

Detailed Description

This is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy in patients with locally advanced cervical cancer. The main inclusive criteria are as follows: histology confirmed cervical cancer; 18-70 years old; 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IIIC2; ECOG score \<=1 point. The estimated enrollment is 200 patients. After enrollment, patients will receive CCRT, including external beam radiotherapy, intracavitary brachytherapy and concurrent chemotherapy. One month after the completion of CCRT, patients will receive 6 cycles of Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy. The primary endpoint is progression free survival. And the secondary endpoints include overall survival, distant metastasis-free survival, local regional recurrence-free survival, acute toxicities, late toxicities, and treatment compliance.

Interventions

Name: Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)
Type: DRUG
Description: CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy

Primary Outcomes

Measure: Progression-free survival
TimeFrame: 3-year/5-year
Description: The time from enrollment to disease progression or death from any cause, whichever is first

Trial Information

NCT ID

NCT04310774

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Peking Union Medical College Hospital

Last Updated

December 15, 2025