AzTrials
AzTrials

Resectable Locally Advanced Thoracic Esophageal Squamous Cell CarcinomaPhase 3NCT04848753

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

A Phase 3 study testing Toripalimab combined with cisplatin and paclitaxel in people with Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 48 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Toripalimab combined with cisplatin and paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
663 participants
Where
48 sitesChina
Study dates
12 May 2021to 12 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

China48 sites

  • Anyang Cancer Hospital

    Anyang, Henan

  • Beijing Cancer Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • The General Hospital of People's Liberation Army

    Beijing

  • The Firest Affiliated Hospital of bengbu Medical College

    Bengbu, Anhui

  • China-Japan Union hosptial of Jilin university

    Changchun, Jilin, 130031

  • Hunan provincial cancer hospital

    Changsha, Hunan, 410013

  • Heping Hospital Affiliated to changzhi Medical College

    Changzhi

  • Sichuan Cancer Hospital & Institute

    Chengdu

  • Fujian Cancer Hospital

    Fuzhou

  • 3201 Hospital

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hanzhou

  • harbin medical university Cancer Hospital

    Harbin

  • Anhui provincial hospital

    Hefei, Anhui, 230001

  • The Second Hospital of anhui Medical University

    Hefei, Anhui

  • Anhui Provincial Cancer Hospital

    Hefei

  • Huai'an First People's Hospital

    Huai'an

  • Jiangmen central Hospital

    Jiangmen, Guangdong

  • The Affiliated Hospital of jining Medical University

    Jining

  • The first affiliated hospital of jinzhou medical university

    Jinzhou, Niaoning, 121001

  • The First Affiliated Hospital of nanchang University

    Nanchang

  • Jiangsu Cancer Hospital

    Nanjing

  • Hwa Mei Hospital,University of Chinese Academy of sciences

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Zhongshan Hospital Fudan University

    Shanghai

  • Shantou University Cancer Hospital

    Shantou

  • Liaoning cancer hospital& Institute

    Shenyang

  • Shengjing Hospital of China Medical University

    Shenyang

  • The first Hospital of china Medical University

    Shenyang

  • Shenzhen people's hosptial

    Shenzhen, Guangdong, 518040

  • The fourth hospital of hebei medical university

    Shijiazhuang, Hebei, 050019

  • Shanxi provincial cancer hosptial

    Taiyuan, Shanxi, 030013

  • Taizhou hospital of zhejiang province

    Taizhou, Zhejiang, 317000

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Hubei Cancer Hospital

    Wuhan

  • Renmin Hospital of Wuhan University

    Wuhan

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen

  • The First Affiliated Hospital of xinxiang Medical University

    Xinxiang, Henan

  • Xinyang central Hospital

    Xinyang

  • The Affiliated Hospital of xuzhou Medical University

    Xuzhou

  • Yantai yuhuangding Hospital

    Yantai

  • Henan provincial pepples hospital

    Zhengzhou, Henan, 450003

  • The first affilated hospital of zhengzhou university

    Zhengzhou, Henan, 450052

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

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

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.

Being tested
Toripalimab combined with cisplatin and paclitaxel, Placebo combined with cisplatin and paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toripalimab combined with cisplatin and paclitaxelCombination product

    Specified doses on specified days.

  • Placebo combined with cisplatin and paclitaxelCombination product

    Specified doses on specified days.

Study groups in NCT04848753
Study groupRoleWhat they receive
Experimental GroupActive comparatorToripalimab combined with cisplatin and paclitaxel
Receives: Combination Product: Toripalimab combined with cisplatin and paclitaxel
Control GroupPlacebo comparatorPlacebo combined with cisplatin and paclitaxel
Receives: Combination Product: Placebo combined with cisplatin and paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare IRC-assessed events-free survival (EFS) in 2 arms

    Measured: 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)

  1. pathologically complete remission (pCR) rate

    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)

    Measured: 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

  2. Investigator-assessed EFS according to RECIST v1.1

    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.

    Measured: 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

  3. Overall survival

    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.

    Measured: 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

  4. 1-year OS rate

    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

    Measured: from randomization to death from any cause at 1 year

  5. 3- year OS rate

    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

    Measured: from randomization to death from any cause at 3 year

  6. 5- year OS rate

    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

    Measured: from randomization to death from any cause at 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start12 May 2021
  3. Primary completion12 May 2027 (estimated)
  4. Study completion12 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04848753
Sponsor's protocol ID
JS001-042-III-ESCC
Status last verified
Apr 2026
First submitted
9 Apr 2021
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toripalimab combined with cisplatin and paclitaxel in people with Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 48 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare IRC-assessed events-free survival (EFS) in 2 arms (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04848753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in