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

Primary Purpose

Esophageal Cancer

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

Paclitaxel

Cisplatin

Placebo

Radiation

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring PD-1Antibody, locally advanced esophageal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Indicators of severe malnutrition;
A history of surgery for esophageal cancer;
Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
Active autoimmune diseases or history of autoimmune diseases that may relapse

Sites / Locations

Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.

Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Outcomes

Primary Outcome Measures

PFS assessed by IRC

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Secondary Outcome Measures

PFS assessed by investigators

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

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.

ORR

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

DoR

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

adverse events

Full Information

NCT ID

NCT04426955

First Posted

June 9, 2020

Last Updated

September 14, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04426955

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 30, 2020 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

PD-1Antibody, locally advanced esophageal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.

Arm Title

Arm B

Arm Type

Placebo Comparator

Arm Description

Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Other Intervention Name(s)

SHR-1210

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

IV infusion

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

Concurrent Radiation

Primary Outcome Measure Information:

Title

PFS assessed by IRC

Description

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

PFS assessed by investigators

Description

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time Frame

up to 3 years

Title

Description

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.

Time Frame

up to 3 years

Title

ORR

Description

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time Frame

up to 3 years

Title

DoR

Description

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Time Frame

up to 3 years

Title

Description

adverse events

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Indicators of severe malnutrition; A history of surgery for esophageal cancer; Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention; Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy; Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies; Active autoimmune diseases or history of autoimmune diseases that may relapse

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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