Trials Sponsors Conditions Drugs Pricing

Conditions

Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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 Outcomes (6)

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
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
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
1-year OS rate
from randomization to death from any cause at 1 year
3- year OS rate
from randomization to death from any cause at 3 year
+1 more secondary outcomes

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

Toripalimab combined with cisplatin and paclitaxel

Combination Product: Toripalimab combined with cisplatin and paclitaxel

Control Group

PLACEBO COMPARATOR

Placebo combined with cisplatin and paclitaxel

Combination Product: Placebo combined with cisplatin and paclitaxel

Interventions

Toripalimab combined with cisplatin and paclitaxelCombination product

Specified doses on specified days.

Experimental Group

Placebo combined with cisplatin and paclitaxelCombination product

Specified doses on specified days.

Control Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Toripalimab combined with cisplatin and paclitaxel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Treatment programme
Placebo combined with cisplatin and paclitaxel
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Shanghai Junshi Bioscience Co., Ltd.
Otherlead

Study Sites (48)

The Firest Affiliated Hospital of bengbu Medical College

Bengbu, Anhui, China

Anhui provincial hospital

Hefei, Anhui, 230001, China

The Second Hospital of anhui Medical University

Hefei, Anhui, China

Jiangmen central Hospital

Jiangmen, Guangdong, China

Shenzhen people's hosptial

Shenzhen, Guangdong, 518040, China

The fourth hospital of hebei medical university

Shijiazhuang, Hebei, 050019, China

Anyang Cancer Hospital

Anyang, Henan, China

MeSH Terms

Interventions

CisplatinPaclitaxel

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

Lin Shen
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR
Yongtao Han
Sichuan Cancer Hospital and Research Institute
PRINCIPAL INVESTIGATOR
Yan Zheng
Henan Cancer Hospital
PRINCIPAL INVESTIGATOR
Keneng Chen
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR

Enrollment

663 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 19, 2021

Study Start

May 12, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Experimental Group

Control Group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (48)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Experimental Group

Control Group

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (48)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations