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

Phase 3

• Conditions: Esophageal Cancer
• Interventions: Drug: Paclitaxel; Drug: Camrelizumab; Drug: Placebo; Drug: Cisplatin; Radiation: Radiation

• Registration Number: NCT04426955
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Radiation	Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
Arm B	Placebo	Placebo + Paclitaxel + Cisplatin + Radiotherapy.
Arm B	Radiation	Placebo + Paclitaxel + Cisplatin + Radiotherapy.
Arm B	Paclitaxel	Placebo + Paclitaxel + Cisplatin + Radiotherapy.
Arm A	Camrelizumab	Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
Arm A	Cisplatin	Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
Arm A	Paclitaxel	Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.
Arm B	Cisplatin	Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Primary Outcome Measures

Name	Time	Method
PFS assessed by IRC	up to 3 years	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
ORR	up to 3 years	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
PFS assessed by investigators	up to 3 years	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
AE	up to 3 years	adverse events
DoR	up to 3 years	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
OS	up to 3 years	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.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China