NCT03603756

SHR-1210 in Combination With Apatinib and Chemotherapy in Patients With Advanced Esophageal Squamous Cell Cancer

SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Apatinib and Irinotecan/Paclitaxel Liposome Plus Nedaplatin in Patients With Previously Untreated Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma are recruited to this prospective non-randomized study comprising two separate cohorts. Patients will receive SHR-1210, a novel anti-PD-1 antibody, with apatinib and either irinotecan or paclitaxel liposome plus nedaplatin. The primary endpoint is to determine the objective response rate (ORR) of patients in both cohorts. The regimen(s) of promising efficacy will be further verified in subsequent randomized studies to define the optimal combination of immunotherapy, anti-angiogenesis and chemotherapy in advanced esophageal cancer patients.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-1210	a novel anti-PD-1 antibody
DRUG	Apatinib	a VEGFR-2 tyrosine kinase inhibitor
DRUG	Irinotecan Injection	cytotoxic agent that binds to topoisomerase I
DRUG	Paclitaxel liposome	cytotoxic agent that prevent depolymerization of cellular microtubules
DRUG	Nedaplatin	cytotoxic agent that cross-links and denatures strands of DNA

Timeline

• Start date: 2018-07-31
• Primary completion: 2020-03-28
• Completion: 2021-03-28
• First posted: 2018-07-27
• Last updated: 2020-02-11

Locations

1 site across 1 country: China