SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer

Hengrui Medicine

Status and phase: Unknown; Phase 2

Conditions: Advanced Esophageal Squamous Cell Cancer

Treatments: Drug: Fluorouracil; Drug: Irinotecan liposome; Drug: SHR-1316

Study type: Interventional

Funder types: Industry

Identifiers

NCT03732508

IRI-SHR-1316-201

Details and patient eligibility

About

The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. ECOG: 0-1;
5. Adequate organ and bone marrow function;

Exclusion criteria

1. Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Irinotecan liposome plus SHR1316 plus fluorouracil

Experimental group

Treatment:

Drug: Fluorouracil

Drug: Irinotecan liposome

Drug: SHR-1316