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A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma

NCT04187352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-11-24

No results posted yet for this study

Summary

Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Conditions

  • Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Interventions

DRUG

CS1001+ Fluorouracil+Cisplatin

CS1001 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W). Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.

DRUG

Placebo+ Fluorouracil+Cisplatin

Placebo 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W). Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2022-10-07
Completion
2022-10-07

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187352 on ClinicalTrials.gov