Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

All patients will receive radiation therapy scheme: 41.4Gy in 23 fractions over 5 weeks, concurrently with 5 cycles of paclitaxel/cisplatin (paclitaxel 45mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22,29 and 2 cycles of toripalimab 240 mg every 3 weeks after chemoradiotherapy. Esophagectomy is performed 6-8 weeks after CRT completion and after operation patients received 4 cycles of toripalimab 240 mg every 3 weeks for adjuvant treatment.

Patients received toripalimab 240mg every 3 weeks 1-7 days after neoadjuvant chemoradiotherapy for 2 cycles before operation and 28-42 days after operation for 4 cycles.

Toripalimab

Xiumei Ma, doctor

Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal squamous cell cancer (ESCC). However, only 20% to 40% of patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis and about 10% of patients have disease progression after chemoradiotherapy. How to improve the the efficacy of neoadjuvant therapy is an important clinical problem to be solved.

Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC especially in ESCC. In Keynote181 study, for patients with metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression, pembrolizumab significantly improved overall survival compared with chemotherapy. However, the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm.

The aim of this study was to evaluate the efficacy and safety of the neoadjuvant chemoradiotherapy combined with perioperative toripalimab in patients with locally advanced esophageal squamous cell cancer.

Neoadjuvant Chemoradiotherapy Combined With Perioperative Toripalimab in Locally Advanced Esophageal Cancer

A Phase II Prospective, Open-label Clinical Trial of Neoadjuvant Chemoradiotherapy Combined With Perioperative Toripalimab in Patients With Locally Advanced Esophageal Squamous Cell Cancer

No more than 10% of tumor cells were found in neoadjuvant surgical specimens.

RenJi Hospital

Irinotecan

Antibodies

Fluorouracil

Immunoglobulins

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Irinotecan liposome intravenous infusion will be administered during the first day of treatment.

Irinotecan liposome

SHR-1316 intravenous infusion will be administered during the first day of treatment.

SHR-1316

Fluorouracil intravenous infusion will be administered during the first day of treatment.

Fei Shi

Jing Huang

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.

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

SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study

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

OS is defined as the time from registration to death due to any cause, or censored at date last known alive.

Jiangsu HengRui Medicine Co., Ltd.

SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor

SHR-1210 plus Anlotinib

Junjie Gu, Doctor

Chunmei Bai, Doctor

This study was designed to explore the clinical efficacy of SHR-1210 in combined with Anlotinib in the treatment of second- or above- line advanced or metastatic esophageal squamous cell cancer patients, in order to find a better therapy strategy for esophageal squamous cell cancer patients.

This is a prospective, phase II, single-arm clinical trial. Advanced or metastatic esophageal squamous cell cancer(ESCC) patients progressed after 1st systematic treatment are treated with SHR-1210 and Anlotinib. SHR-1210 was given intravenously(200mg d1 Q2w), combined with Anlotinib orally, 12 mg d1-14 Q3w. The hypothesis: The objective response rate in SHR-1210 combined with Anlotinib can reach 40% as second-line or above treatment of advanced or metastatic ESCC patients. The primary endpoint is objective response rate (ORR) and the secondary endpoint is disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety of this regimen.

SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer

SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Anlotinib As Second-line or Above Treatment in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study

Objective response rate based on RECIST v1.1 by investigators

Disease control rate based on RECIST v1.1 by investigators

Overall survival based on RECIST v1.1 by investigators

Progression free survival based on RECIST v1.1 by investigators

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Chemoradiotherapy Combined With Perioperative Toripalimab in Locally Advanced Esophageal Cancer	NCT04437212	Advanced Esopha...	Toripalimab	18 Years - 75 Years	RenJi Hospital
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer	NCT03732508	Advanced Esopha...	Irinotecan lipo... SHR-1316 Fluorouracil	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer	NCT04797507	SHR-1210 Anlotinib Advanced Esopha...	SHR-1210 plus A...	18 Years - 75 Years	Peking Union Medical College Hospital
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer	NCT03732508	Advanced Esopha...	Irinotecan lipo... SHR-1316 Fluorouracil	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer	NCT03732508	Advanced Esopha...	Irinotecan lipo... SHR-1316 Fluorouracil	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for advanced esophageal squamous cell cancer