A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma

Phase 3

Completed

• Conditions: Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Placebo+ Fluorouracil+Cisplatin; Drug: CS1001+ Fluorouracil+Cisplatin

• Registration Number: NCT04187352
• Lead Sponsor: CStone Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2019-12-19
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo+ Fluorouracil+Cisplatin	Placebo+ Fluorouracil+Cisplatin	-
CS1001+ Fluorouracil+Cisplatin	CS1001+ Fluorouracil+Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Approximately 43 months from the time of randomization	OS was defined as the time from randomization to death due to any cause.
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Approximately 43 months from the time of randomization	PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR) assessed by BICR and investigators according to RECIST v1.1	Approximately 43 months from the time of randomization	DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first.
PFS assessed by investigators according to RECIST v1.1	Approximately 43 months from the time of randomization	PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by investigators, or death due to any cause, whichever occurred first.
Objective response rate (ORR) assessed by BICR and investigators according to RECIST v1.1	Approximately 43 months from the time of randomization	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) or a Partial Response (PR) per RECIST 1.1.

Trial Locations

Locations (72)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Hefei Second People's Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

Peaking University International Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing General Hospital; 🇨🇳 Chongqing, Chongqing, China

Special Medical Center of The People's Liberation Army of China; 🇨🇳 Chongqing, Chongqing, China

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