Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04848753
• Collaborator: (none)
• Enrollment: 500
• Locations: 48
• Arms: 2
• Anticipated Duration (Months): 65.8
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma	Combination Product: Toripalimab combined with cisplatin and paclitaxel; Combination Product: Placebo combined with cisplatin and paclitaxel	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
• Actual Study Start Date: Jun 18, 2021
• Anticipated Primary Completion Date: Sep 17, 2023
• Anticipated Study Completion Date: Dec 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental Group Toripalimab combined with cisplatin and paclitaxel	Combination Product: Toripalimab combined with cisplatin and paclitaxel; Specified doses on specified days.
Placebo Comparator: Control Group Placebo combined with cisplatin and paclitaxel	Combination Product: Placebo combined with cisplatin and paclitaxel; Specified doses on specified days.

Outcome Measures

Primary Outcome Measures

1. To compare IRC-assessed events-free survival (EFS) in 2 arms [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months]

Secondary Outcome Measures

1. pathologically complete remission (pCR) rate [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months]

   To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR)

2. Investigator-assessed EFS according to RECIST v1.1 [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months]

   To compare Investigator-assessed events-free survival (EFS) in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

3. Overall survival [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months]

   To compare Overall survival in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

4. 1-year OS rate [from randomization to death from any cause at 1 year]

   To compare 1-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy

5. 3- year OS rate [from randomization to death from any cause at 3 year]

   To compare 3-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy

6. 5- year OS rate [from randomization to death from any cause at 5 year]

   To compare 5-year OS rates in patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:

1. Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification);

2. No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;

3. Expected to be achievable to conduct R0 resection.

Patients must not enter this study if any of the following exclusion criteria is fulfilled:

1. Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;

2. Combined with other inoperable condition;

3. Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;

4. Combined with other conditions unsuitable for participation in this study as judged by investigators.

Other protocol defined Inclusion/exclusion criteria could apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Firest Affiliated Hospital of bengbu Medical College	Bengbu	Anhui	China
2	Anhui provincial hospital	Hefei	Anhui	China	230001
3	The Second Hospital of anhui Medical University	Hefei	Anhui	China
4	Jiangmen central Hospital	Jiangmen	Guangdong	China
5	Shenzhen people's hosptial	Shenzhen	Guangdong	China	518040
6	The fourth hospital of hebei medical university	Shijiazhuang	Hebei	China	050019
7	Anyang Cancer Hospital	Anyang	Henan	China
8	The First Affiliated Hospital of xinxiang Medical University	Xinxiang	Henan	China
9	Henan provincial pepples hospital	Zhengzhou	Henan	China	450003
10	The first affilated hospital of zhengzhou university	Zhengzhou	Henan	China	450052
11	Hunan provincial cancer hospital	Changsha	Hunan	China	410013
12	China-Japan Union hosptial of Jilin university	Changchun	Jilin	China	130031
13	The first affiliated hospital of jinzhou medical university	Jinzhou	Niaoning	China	121001
14	Shanxi provincial cancer hosptial	Taiyuan	Shanxi	China	030013
15	Affiliated Tumor Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	China
16	Hwa Mei Hospital,University of Chinese Academy of sciences	Ningbo	Zhejiang	China	315010
17	Taizhou hospital of zhejiang province	Taizhou	Zhejiang	China	317000
18	Beijing Cancer Hospital	Beijing		China
19	Peking University Third Hospital	Beijing		China
20	The General Hospital of People's Liberation Army	Beijing		China
21	Heping Hospital Affiliated to changzhi Medical College	Changzhi		China
22	Sichuan Cancer Hospital & Institute	Chengdu		China
23	Fujian Cancer Hospital	Fuzhou		China
24	3201 Hospital	Hangzhou		China
25	Zhejiang Cancer Hospital	Hangzhou		China
26	The First Affiliated Hospital, Zhejiang University School of Medicine	Hanzhou		China
27	harbin medical university Cancer Hospital	Harbin		China
28	Anhui Provincial Cancer Hospital	Hefei		China
29	Huai'an First People's Hospital	Huai'an		China
30	The Affiliated Hospital of jining Medical University	Jining		China
31	The First Affiliated Hospital of nanchang University	Nanchang		China
32	Jiangsu Cancer Hospital	Nanjing		China
33	The Affiliated Hospital of Qingdao University	Qingdao		China
34	Zhongshan Hospital Fudan University	Shanghai		China
35	Shantou University Cancer Hospital	Shantou		China
36	Liaoning cancer hospital& Institute	Shenyang		China
37	Shengjing Hospital of China Medical University	Shenyang		China
38	The first Hospital of china Medical University	Shenyang		China
39	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China
40	Hubei Cancer Hospital	Wuhan		China
41	Renmin Hospital of Wuhan University	Wuhan		China
42	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan		China
43	The First Affiliated Hospital of Xiamen University	Xiamen		China
44	Zhongshan Hospital Affiliated to Xiamen University	Xiamen		China
45	Xinyang central Hospital	Xinyang		China
46	The Affiliated Hospital of xuzhou Medical University	Xuzhou		China
47	Yantai yuhuangding Hospital	Yantai		China
48	Henan Cancer Hospital	Zhengzhou		China

Sponsors and Collaborators

• Shanghai Junshi Bioscience Co., Ltd.

Investigators

• Principal Investigator: Lin Shen, Peking University Cancer Hospital & Institute
• Principal Investigator: Yongtao Han, Sichuan Cancer Hospital & Institute
• Principal Investigator: Yan Zheng, Henan Cancer Hospital
• Principal Investigator: Keneng Chen, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04848753
• Other Study ID Numbers: JS001-042-III-ESCC
• First Posted: Apr 19, 2021
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Paclitaxel; Albumin-Bound Paclitaxel; Cisplatin

Study Results

No Results Posted as of Apr 25, 2022