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Immunotherapy combo shows promise in advanced nasopharyngeal cancer trial

NCT ID NCT03581786

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding the immunotherapy drug toripalimab to standard chemotherapy helps people with recurrent or metastatic nasopharyngeal cancer live longer without their disease getting worse. About 289 adults with advanced cancer that could not be treated with local therapies were randomly assigned to receive either toripalimab plus chemo or a placebo plus chemo. The main goal was to see if the combination slowed cancer progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
toripalimab (an immunotherapy drug) combined with chemotherapy (gemcitabine and cisplatin)
What this could lead to
If it works, this could offer a new first-line treatment option for people with advanced nasopharyngeal cancer, potentially slowing disease progression.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. Immunotherapy can cause immune-related side effects, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

289 people

The number who actually took part.

Started

Oct 2018

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Age ≥ 18 years and ≤75 years. * 2\. Histological/cytological confirmation of NPC. * 3\. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment. * 4\. At least 1 measurable lesion according to RECIST version 1.1. * 5\. Life expectancy ≥ 3 months Exclusion Criteria: * 1\. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001. * 2\. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor. * 3\. Major surgical procedure other than for diagnosis of NPC within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study * 4\. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients. * 5\. Female patients who are at pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent or metastatic NPC

Contacts and locations

Locations

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095, China

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangzhou, 130012, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangzhou, 515031, China

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350000, China

  • Hainan General Hospital (Hainan Province People's Hospital)

    Haikou, Hainan, 570311, China

  • Hebei Oncology Hospital

    Shijiazhuang, Hebei, 50011, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Jiangsu Oncology Hospital

    Nanjing, Jiangsu, 210000, China

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029, China

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545000, China

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515, China

  • National Cancer Centre

    Singapore, 169610, Singapore

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • TaiChung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000, China

  • The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology

    Zhuhai, Guangzhou, 519000, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital

    Wuhan, Hubei, 430030, China

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

    Wuhan, Hubei, 430023, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China