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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04890522
Other study ID # B2020-409-01
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2028

Study information

Verified date May 2021
Source Sun Yat-sen University
Contact Yun-fei Xia, MD
Phone +8613602805461
Email xiayf@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 622
Est. completion date December 31, 2028
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Nasopharyngeal carcinoma diagnosed by pathology or cytology. - Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) is not amenable for local-regional treatment or curative treatment. - Has not received prior systemic treatment for metastatic nasopharyngeal carcinoma, except for neoadjuvant chemotherapy, concurrent chemoradiotherapy, or adjuvant chemotherapy 6 months prior to the first treatment. - The Karnofsky performance status score is at least 70 points (if the decreased score is caused by the tumor, the minimum score can be 50 points after the judgment of researchers.) - Has at least one measurable target lesion based on RECIST v1.1, which is never received local treatment like radiotherapy. - Life expectancy = 3 months. - The lab examination results of the screening must fulfill all of the following (use of any blood components, hematopoietic stimulating factors, etc. are not allowed within 14 days before screening): 1. absolute neutrophil count =1.5×10^9/ L; 2. platelet count = 100×10^9/ L; 3. hemoglobin = 8.0 g/dL; 4. serum albumin = 2.8g/dL; 5. aspartate transferase(AST) and alanine transferase(ALT) = 1.5 ×ULN; total bilirubin = 1.5×ULN (if has liver metastasis, AST and ALT = 5×ULN); 6. creatinine clearance >50 mL/min. - Men with reproductive capacity or women of childbearing potential must use highly effective contraceptive methods during the trial (e.g., oral contraceptives, intrauterine device, sexual abstinence or barrier method combined with spermicide), and continue contraception for 3 months after the last injection of JS001 and 6 months after the end of chemotherapy. - Has signed the Informed Consent Form. Exclusion Criteria: - Allergic to monoclonal antibodies, any JS001 components, gemcitabine, cisplatin, or 5-fluorouracil. - Has prior therapy including anti-PD-1, anti-PD-L1, or CTLA4. - Major surgery within 28 days prior to the randomization (not including diagnostic surgery) or plan to be conducted during the study. - Active autoimmune disease requiring systemic treatment or has a history of autoimmune disease. - Requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. - Allergic to macromolecular protein preparation ingredients. - Has central nervous system (CNS) metastasis with clinical symptoms. - Had other invasive malignant diseases, except excised basal-cell skin carcinoma, cervical carcinoma in situ, or other cancers curatively treated more than 5 years before study entry. - Has cardiac clinical symptoms or disease out of control. - Has an active infection or unexplained fever with more than 38.5 ? during screening and prior to first administration. - Has acquired or congenital immune-deficient disease, or active hepatitis. - History of drug abuse or alcohol abuse. - The investigator judges other factors that may lead to the forced termination of this study, including but not limited to: other serious conditions (including mental disorder) that require concomitant treatment, severe laboratory test abnormalities, family or social factors that may affect the safety of patients or the collection of trial data and samples. - Pregnancy or breast feeding.

Study Design


Intervention

Drug:
Triprilimab(JS001)
Maximum 6 cycles for combined therapy and maintenance for up to 2 years.
Cisplatin
Maximum 6 cycles for combined therapy.
5-Fluorouracil
Maximum 6 cycles for combined therapy.
Gemcitabine
Maximum 6 cycles for combined therapy.

Locations

Country Name City State
China Department of Radiation Oncology, Sun Yat-Sen University Cancer Center Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary PFS Progression-free survival Up to 5 years
Primary OS Overall survival Up to 5 years
Primary Severe drug-related adverse events grade III-V according to CTCAE v4.0 Up to 2 approximately years
Secondary ORR Objective response rate Up to 2 approximately years
Secondary DCR Disease control rate Up to 2 approximately years
Secondary DOR Duration of response Up to 2 approximately years
Secondary Minor drug-related adverse events grade I-II according to CTCAE v4.0 Up to 2 approximately years
Secondary Quality-adjusted survival Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (Q-TWiST), a measure involving the partitioning of survival duration into clinically relevant health states (e.g., treatment toxicity, disease progression, progression-free), assigning preference weights (or utilities) to these health states, and calculating quality of life-adjusted weighted sums of the mean duration of each health state to create the overall Q-TWiST scores. Up to 5 years
Secondary Therapeutic gain Calculated by dividing person-year rate of overall survival by person-year rate of serious toxicity. Up to 2 approximately years
Secondary Incremental Cost-Effectiveness Ratio (ICER) To estimate the costs and health gains of different interventions, calculated as incremental cost divided by life years gained. Up to 2 approximately years
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