Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

Advanced Esophageal Cancer Clinical Trial

Official title:

PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691090
• Other study ID #: SHR-1210-III-306
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2022
• 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 SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. 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. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: April 30, 2022
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;

2. No previous systemic anti-tumor treatment;

3. Subjects must have at least one measurable tumor lesion per RECIST 1.1;

4. Tissue samples should be provided for biomarkers (such as PD-L1) analysis;

5. ECOG: 0-1;

6. Adequate organ and bone marrow function;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;

2. Prior therapy as follow:

1. Anti-PD-1 or anti-PD-L1;

2. Any experimental drugs within 4 weeks of the first dose of study medication;

3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;

4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;

3. Not recovered to =CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;

4. Subjects with any active autoimmune disease or history of autoimmune disease;

5. Pregnancy or breast feeding;

Related Conditions & MeSH terms

• Advanced Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• SHR-1210
SHR-1210 200mg
• Placebo
Placebo
• paclitaxel
paclitaxel 175mg/m2
• cisplatin
cisplatin 75mg/m2

Locations

Country	Name	City	State
China	Cancer Center of Sun-Yat Sen University (CCSYSU)	Guangzhou	Guangdong

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
Other	Antidrug Antibodies (ADAs)	To evaluate the incidence of ADAs against SHR-1210	approximately 22 months
Primary	PFS assessed by IRC	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Primary	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.	approximately 22 months
Secondary	PFS assessed by investigators	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	6 and 9 month OS rate	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.	approximately 6 and 9 months
Secondary	ORR	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	DCR	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	DoR	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)	approximately 22 months
Secondary	AE	adverse events	approximately 22 months