The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

NCT ID: NCT03581786

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2022-11-18

Brief Summary

This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.

Detailed Description

Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).

Conditions

Recurrent or Metastatic NPC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo combine with chemotherapy

Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

placebo combine with chemotherapy

TORIPALIMAB INJECTION(JS001 )combine with chemotherapy

Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years

Group Type: EXPERIMENTAL

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Intervention Type: BIOLOGICAL

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Interventions

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Intervention Type: BIOLOGICAL

Placebos

placebo combine with chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruihua Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Liuzhou Worker's Hospital

Liuzhou, Guangxi, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangzhou, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangzhou, China

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

Zhuhai, Guangzhou, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hainan General Hospital (Hainan Province People's Hospital)

Haikou, Hainan, China

Hebei Oncology Hospital

Shijiazhuang, Hebei, China

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Oncology Hospital

Nanjing, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

National Cancer Centre

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

China Medical University Hospital

Taichung, , Taiwan

TaiChung Veterans General Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

China; Singapore; Taiwan

References

Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.

Reference Type: DERIVED

PMID: 38015220 (View on PubMed)

Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. doi: 10.1038/s41591-021-01444-0. Epub 2021 Aug 2.

Reference Type: DERIVED

PMID: 34341578 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

JS001-015-III-NPC

Identifier Type: -

Identifier Source: org_study_id