Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

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

Carboplatin

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Two cycles of induction chemotherapy (nab-paclitaxel, 200 mg/m2/day, day1; carboplatin, area under the curve of 5 mg/ml/min, day 1) combined with PD-1 inhibitors （Sintilimab, 200 mg/day, day 1）every 3 weeks followed by concurrent chemoradiotherapy. Patients without progressive disease（PD） will proceed to receive immunotherapy (Sintilimab, 200 mg/day, every 3 weeks) as maintenance treatment for at least 1 year.

Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

chemotherapy combined with PD-1 inhibitors

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.

Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)

A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer

Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment

Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events.

Shanghai Chest Hospital

associate proffessor

Nimotuzumab

Cisplatin

Tubulin Modulators

Antimitotic Agents

400mg,day1,weekly,until disease progression or toxicity

175mg/m\^2,for 3 hour(Peripherally Inserted Central Catheter,PICC),day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.

60mg/m\^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.

Placebo

Lin Shen, Dr

Jun Zhou

Bin Hu

Lin Shen, Ph.D

Jing Huang

Guanghai Dai

Quanli Han

Chunmei Bai

Ning Jia

Jianming Xu

Yuling Chen

Cheng Huang

Wu Zhuang

Xiaoyan Lin

Ruihua Xu, Dr

Dongsheng Zhang

Ruihua Xu

Yingcheng Lin

Yuxian Bai

Xiaoli Wei

Qingxia Fan

Wang Ma

Liuxing Wang

Xianli Yin

Shaofeng Jiang

XianliXianli Yin

Yongqian Shu

Lianke Liu

Dong Hua

Yong Mao

Ying Cheng

Yanrong Wang

Tao Sun

Xiaoxin Wang

Mei Wang

Qiang Fu

Jun Zhang

Xinfang Shangguan

Tianshu Liu

Yiwei Yu

Enxiao Li

Xin Wang

Li Peng

Di Lu

Feng Peng

Yi Yi

Jinhuai Xue

Hongming Pan

Yu Zheng

Ying Yuan

Caixia Dong

Yiping Zhang

Guangyuan Lou

This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.

This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with TP compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.The main endpoint is OS.

Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma

An Prospective, Multicenter, Double-blind, Randomized, Controlled Clinical Study of Nimotuzumab Combined With Paclitaxel and Cisplatin as First-line Treatment of Metastatic Esophageal Squamous Cell Carcinomas

Record all the survival status of each patient and calculate the median OS of all the patients

PFS is the time that passes from the date of signing Informed Consent Form（ICF）to the data on which "progresses" or the date on which the patient dies from any cause. The definition of "progression" since this generally involves imaging techniques(CT,MRI,et al).The Response Evaluation Criteria In Solid Tumors (RECISIT) 1.1 criteria will be used to evaluate "progression".The imaging evaluation will be done every 6 weeks.

This wil be evaluated by RECISIT 1.1 criteria.It is dependent on imaging evaluation which will be done every 6 weeks. ORR is the percent of the patient who is evaluated as complete response(CR) or partial response (PR),that is (CR+PR)%.

Using the European Organization for Research and Treatment of Cancer（EORTC）quality of life questionnaire（QLQ）-C30（Version3.0）and EORTC QLQ - OES18 to evaluate the quality of life of patients. The patients will fill this questionnaire when signing the ICF(as baseline) and every 6 weeks during treatment,until disease progression,up to 52 weeks. The progression is from date of randomization until the date of first documented progression or date of death from any cause.

Biotech Pharmaceutical Co., Ltd.

Pembrolizumab

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors（pembrolizumab，200mg d1） every 3 weeks for 4 cycles followed by PD-1 inhibitors（pembrolizumab，200mg d1）every 3 weeks up to 2 years in a standard manner.

immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP

PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.

Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy

Salvage Immunotherapy Combined With Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE Study)

Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.

Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date").

Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery

Antibodies

Immunoglobulins

The adjuvant treatment of radiotherapy combined with carrilizumab lasted for 6 cycles

Camrelizumab

radiotherapy

Zhichao Fu, Prof

zhichao Fu

This is an investigator-initiated, single-arm, single-center, exploratory clinical study.The study population consisted of patients with R0 resection of esophageal squamous cell carcinoma who had not received radiation therapy.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with radiotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.About 20 subjects are planned to be enrolled in this study.Drug regimen: Patients with esophageal squamous cell carcinoma received radiotherapy combined with carrilizumab adjuvant therapy for 6 cycles 1-3 months after R0 resection.

Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery

A Single-arm, Exploratory Clinical Study of Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery

The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later.

the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.

The time from enrolment (ICF signing) to disease recurrence or death due to disease progression.

the time between subjects' death from various causes.For subjects still alive at the last follow-up, their OS was measured as data deletion by the time of the last follow-up.

Fuzhou General Hospital

Symptoms and General Pathology

Recurrence

Irinotecan

Antibodies, Monoclonal

Topoisomerase I Inhibitors

Enzyme Inhibitors

Patients with recurrent metastatic esophageal squamous cell carcinoma who had failed first-line therapy with PD-1(L1) monoclonal antibody plus platinum-based chemotherapy were enrolled.

Administered by intravenous drip every 2 weeks (Q2W). The first intravenous infusion is 120 min±10min. If the infusion reaction can be tolerated during the first infusion, the subsequent infusion can be completed in 60-120 min.

SI-B001

The dose of irinotecan was 180mg/m2 Q2W, the infusion method was according to the drug instructions, SI-B001 and irinotecan were used on the same day, and irinotecan was injected after SI-B001 infusion.

Hai Zhu

Sa Xiao

Lin Shen

Junsheng Wang

Shegan Gao

Yuan Yuan

Mudan Yang

Na Li

This multi-center, open label Phase II clinical study is performed in patients with relapsed and metastatic esophageal squamous cell carcinoma progressed on prior PD-1/L1 antibody with or without chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with irinotecan in patients.

SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.

Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 Combined With Irinotecan in the Treatment of Recurrent and Metastatic Esophageal Squamous Cell Carcinoma

Optimal combination dose of SI-B001 with irinotecan(only IIa)

Sichuan Baili Pharmaceutical Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)	NCT05621707	Esophageal Squa... Concurrent Chem... Immunotherapy Chemotherapy	chemotherapy co...	18 Years - 75 Years	Shanghai Chest Hospital
Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma	NCT02611700	Esophageal Squa...	Nimotuzumab Paclitaxel Cisplatin Placebo	18 Years -	Biotech Pharmaceutical Co., Ltd.
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy	NCT05103501	Esophageal Squa...	PF regimen (cis...	18 Years - 75 Years	Shanghai Chest Hospital
Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery	NCT04741490	Esophageal Squa...	Camrelizumab radiotherapy	18 Years - 75 Years	Fuzhou General Hospital
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy	NCT05103501	Esophageal Squa...	PF regimen (cis...	18 Years - 75 Years	Shanghai Chest Hospital
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy	NCT05103501	Esophageal Squa...	PF regimen (cis...	18 Years - 75 Years	Shanghai Chest Hospital
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.	NCT05022654	Esophageal Squa...	SI-B001 Irinotecan	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for esophageal squamous cell carcinomas