Combination of Chemotherapy Plus RT and SHR-1210 to Treat Patients With ESCC

Tianjin Medical University

Status: Unknown

Conditions: Esophageal Cancer

Treatments: Radiation: IMRT or VMAT; Drug: Apatinib; Drug: SHR-1210

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03671265

SHR-1210-CRT-ESC-IIT

Details and patient eligibility

About

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an openlabel，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 and chemotherapy in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age:18-75 years, male or female.
2. Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
3. Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 6 months.
8. Patient has given written informed consent.

Exclusion criteria

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.

2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.

3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);

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

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5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;

6. Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);

7. Received a live vaccine within 4 weeks of the first dose of study medication.

8. Pregnancy or breast feeding.

9. Decision of unsuitableness by principal investigator or physician-incharge.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SHR-1210 + Chemotherapy + Radiotherapy

Experimental group

Description:

Radiotherapy(IMRT or VMAT): 95%PTV 54Gy/30 fraction,95%PTV 60Gy/30 fraction ,5 fractions per week, for 6 weeks. Radiation begun the day on which first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes. Chemotherapy: Docetaxel 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22, total 4 cycles; Cisplatin 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22;, total 4 cycles. Apatinib: 250mg/d，PO Qd(4 weeks after Radiotherapy, until the end of 8th ycle )

Treatment:

Drug: SHR-1210

Drug: Apatinib

Radiation: IMRT or VMAT