A Multicenter, Randomized Controlled, Phase II Clinical Study of First-line Chemotherapy and Camrelizumab With or Without Radiotherapy in the Treatment of Oligometastatic Esophageal Cancer

Summary

A multi-center, open, randomized controlled, phase II clinical study to evaluate the efficiency and safety of chemotherapy and immunotherapy combined with locol radiotharepy in treatment of patients with oligometastatic esophageal carcinoma.

Conditions

• Esophageal Cancer

Interventions

RADIATION

Radiotherapy group

Stereotactic body radiotherapy (SBRT, 8Gy/time, 3 -5 times, if other segmentation schemes are used, recommend BED10 \>60Gy) or conventional fractional radiotherapy (parts that are not suitable for SBRT, the total dose is more than 30Gy); the primary lesion should be treated with conventional fractional radiotherapy with a dose of 4000cGy or more;

DRUG

Camrelizumab

4 cycles for combined therapy. Camrelizumab maintenance.

DRUG

Chemotherapy

4 cycles for combined therapy.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Wenzhou Medical Univercity

  collaborator UNKNOWN

• Jinhua Municipal Central Hospital

  collaborator OTHER

• Lishui Municipal Central Hospital

  collaborator OTHER_GOV

• The Affiliated People's hospital of Ningbo Univercity

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• People's Hospital of Quzhou

  collaborator OTHER

• Sun Yet-sen Cancer Center

  collaborator UNKNOWN

• Zhejiang Cancer Hospital

  lead OTHER

Principal Investigators

• yongling Ji, MD · Zhejiang Cancer Hospital

• Xianghui Du, MD · Zhejiang Cancer Hospital

• Ming Chen, MD · Sun Yet-sen Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-31

Primary Completion

2023-12-01

Completion

2025-12-01

Countries

• China

Study Locations