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Trial Title:
SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma
NCT ID:
NCT05524168
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine
Conditions: Keywords:
SBRT
PD-1 antibody
Chemotherapy
Efficacy
Safety
Oligometastasis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT
Description:
SBRT for metastatic lesions
Arm group label:
SBRT+PD-1+Chemotherapy
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.
Arm group label:
SBRT+PD-1+Chemotherapy
Other name:
SHR-1210
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Maximum 6 cycles for combined therapy.
Arm group label:
SBRT+PD-1+Chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Maximum 6 cycles for combined therapy.
Arm group label:
SBRT+PD-1+Chemotherapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingjing Miao, MD.
Phone:
13631355201
Email:
miaojj@sysucc.org.cn
Investigator:
Last name:
Chong Zhao, MD. PhD.
Email:
Principal Investigator
Start date:
November 25, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Shenzhen People's Hospital
Agency class:
Other
Collaborator:
Agency:
First People's Hospital of Foshan
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524168
