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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05524168
Other study ID # SBRT+PD-1+Chemo for mNPC
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 25, 2022
Est. completion date September 2025

Study information

Verified date June 2023
Source Sun Yat-sen University
Contact Jingjing Miao, MD.
Phone 13631355201
Email miaojj@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT combined with programmed death 1 (PD-1) antibody and chemotherapy in nasopharyngeal carcinoma patients with oligometastasis.


Recruitment information / eligibility

Status Recruiting
Enrollment 41
Est. completion date September 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Diagnosed as metastatic NPC with no more than 3 metastatic lesions; - Histopathological diagnosis of NPC; - ECOG 0-1 point; - Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; - No contraindications to immunotherapy and chemoradiotherapy; - Every metastatic lesions could receive SBRT safely; - Subject must have a measurable target lesion based on RECIST v1.1; - Adequate marrow function: WBC count = 3×10E9/L, NE count = 1.5×10E9/L, HGB = 90g/L, PLT count = 100×10E9/L; - Adequate liver function: ALT/AST = 2.5×ULN, TBIL = 2.0×ULN; - Adequate renal function: BUN/CRE = 1.5×ULN or endogenous creatinine clearance = 60ml/min (Cockcroft-Gault formula); - Take effective contraceptions during and three months after treatment; - Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: - Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin; - Unexplained fever > 38.5 ?, except for tumor fever; - Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); - Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA =10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; - Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway; - Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy; - Pregnant or breastfeeding; - Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; - Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; - Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT
SBRT for metastatic lesions
Drug:
Camrelizumab
Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.
Gemcitabine
Maximum 6 cycles for combined therapy.
Cisplatin
Maximum 6 cycles for combined therapy.

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (6)

Lead Sponsor Collaborator
Sun Yat-sen University Chongqing University Cancer Hospital, First People's Hospital of Foshan, Jiangxi Provincial Cancer Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first. up to 12 months
Secondary Overall Survival Defined as the time from randomization to death from any cause. up to 12 months
Secondary Objective Response Rate The percentage of patients with CR and PR assessed according to RECIST v1.1. up to 12 months
Secondary Disease Control Rate The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1. up to 12 months
Secondary Adverse Events All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03 up to 12 months
Secondary QoL Assessed by EQ-5D-5L questionnaire up to 12 months
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