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

NCT03691090 | Completed Phase 3

• 1 other identifier: SHR-1210-III-306
• Study Type: interventional
• Target: 596
• 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 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.

Conditions

Advanced Esophageal Cancer

Keywords

PD-1Antibody; advanced esophageal cancer; paclitaxel; cisplatin

Outcome Measures

Primary Outcomes (2)

• PFS assessed by IRC

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

  approximately 22 months

• 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 Outcomes (6)

• PFS assessed by investigators

  approximately 22 months

• 6 and 9 month OS rate

  approximately 6 and 9 months

• ORR

  approximately 22 months

• DCR

  approximately 22 months

• DoR

  approximately 22 months

Other Outcomes (1)

• Antidrug Antibodies (ADAs)

  approximately 22 months

Study Arms (2)

SHR-1210 + paclitaxel + cisplatin

EXPERIMENTAL

Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance

Drug: SHR-1210; Drug: paclitaxel; Drug: cisplatin

placebo+paclitaxel + cisplatin

ACTIVE COMPARATOR

Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance

Drug: Placebo; Drug: paclitaxel; Drug: cisplatin

Interventions

SHR-1210 DRUG

SHR-1210 200mg

Also known as: camrelizumab

SHR-1210 + paclitaxel + cisplatin

Placebo DRUG

Placebo

placebo+paclitaxel + cisplatin

paclitaxel DRUG

paclitaxel 175mg/m2

SHR-1210 + paclitaxel + cisplatin; placebo+paclitaxel + cisplatin

cisplatin DRUG

cisplatin 75mg/m2

SHR-1210 + paclitaxel + cisplatin; placebo+paclitaxel + cisplatin

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
• No previous systemic anti-tumor treatment;
• Subjects must have at least one measurable tumor lesion per RECIST 1.1;
• Tissue samples should be provided for biomarkers (such as PD-L1) analysis;
• ECOG: 0-1;
• Adequate organ and bone marrow function;

You may not qualify if:

• Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs;
• Prior therapy as follow:
• Anti-PD-1 or anti-PD-L1;
• Any experimental drugs within 4 weeks of the first dose of study medication;
• Received major operations or serious injuries within 4 weeks of the first dose of study medication;
• Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
• Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
• Subjects with any active autoimmune disease or history of autoimmune disease;
• Pregnancy or breast feeding;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Cancer Center of Sun-Yat Sen University (CCSYSU)

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

• Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.

  PMID: 37139963 DERIVED

• Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.

  PMID: 34519801 DERIVED

MeSH Terms

Interventions

camrelizumab; Paclitaxel; Cisplatin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ruihua Xu

  Cancer Center of Sun-Yat Sen University (CCSYSU)

  PRINCIPAL INVESTIGATOR

• Qing Yang

  Jiangsu HengRui Medicine Co., Ltd.

  STUDY DIRECTOR

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: September 21, 2018
• First Posted: October 1, 2018
• Study Start: December 3, 2018
• Primary Completion: October 30, 2020
• Study Completion: April 30, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)