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

NCT04426955 | Unknown Phase 3

• 1 other identifier: SHR-1210-III-323
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

PD-1Antibody; locally advanced esophageal cancer

Outcome Measures

Primary Outcomes (1)

• PFS assessed by IRC

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

  up to 3 years

Secondary Outcomes (5)

• PFS assessed by investigators

  up to 3 years

• OS

  up to 3 years

• ORR

  up to 3 years

• DoR

  up to 3 years

• AE

  up to 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

Camrelizumb + Paclitaxel + Cisplatin + Radiotherapy.

Drug: Camrelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation

Arm B

PLACEBO COMPARATOR

Placebo + Paclitaxel + Cisplatin + Radiotherapy.

Drug: Paclitaxel; Drug: Cisplatin; Drug: Placebo; Radiation: Radiation

Interventions

Camrelizumab DRUG

IV infusion

Also known as: SHR-1210

Arm A

Paclitaxel DRUG

IV infusion

Arm A; Arm B

Cisplatin DRUG

IV infusion

Arm A; Arm B

Placebo DRUG

IV infusion

Arm B

Radiation RADIATION

Concurrent Radiation

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab; Paclitaxel; Cisplatin; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: June 30, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)