Clinical trial NCT05524168: SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma
Official title: SBRT Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Nasopharyngeal Carcinoma With Oligometastasis: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: SBRT
PD-1 antibody
Chemotherapy
Efficacy
Safety
Oligometastasis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen People's Hospital
name: First People's Hospital of Foshan
name: Jiangxi Provincial Cancer Hospital
name: The First Affiliated Hospital of Xiamen University
name: Chongqing University Cancer Hospital
First posted: 2022-09-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: up to 12 months
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 12 months
measure: Objective Response Rate
timeFrame: up to 12 months
measure: Disease Control Rate
timeFrame: up to 12 months
measure: Adverse Events
timeFrame: up to 12 months
measure: QoL
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: