Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04426955
• Other study ID #: SHR-1210-III-323
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 30, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.

Description:

In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 396
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status = 1; 5.Adequate organ function

Exclusion Criteria:

1. Indicators of severe malnutrition;

2. A history of surgery for esophageal cancer;

3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;

4. Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;

5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;

6. Active autoimmune diseases or history of autoimmune diseases that may relapse

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Camrelizumab
IV infusion
• Paclitaxel
IV infusion
• Cisplatin
IV infusion
• Placebo
IV infusion

Radiation:
• Radiation
Concurrent Radiation

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS assessed by IRC	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	up to 3 years
Secondary	PFS assessed by investigators	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	up to 3 years
Secondary	OS	OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.	up to 3 years
Secondary	ORR	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	up to 3 years
Secondary	DoR	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	up to 3 years
Secondary	AE	adverse events	up to 3 years