Clinical trial
Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial
Name
SBRT/LDRT+PD-1+GP for r/mNPC
Description
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Trial arms
Trial start
2024-04-01
Estimated PCD
2026-04-01
Trial end
2028-04-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
SBRT
SBRT for metastatic lesions
Arms:
SBRT+LDRT+PD-1+Chemotherapy
Low-dose Radiotherapy (LDRT)
LDRT for metastatic lesions
Arms:
SBRT+LDRT+PD-1+Chemotherapy
Toripalimab
6 cycles for combined therapy. Toripalimab maintenance for 1 year.
Arms:
SBRT+LDRT+PD-1+Chemotherapy
Gemcitabine
6 cycles for combined therapy.
Arms:
SBRT+LDRT+PD-1+Chemotherapy
Cisplatin
6 cycles for combined therapy.
Arms:
SBRT+LDRT+PD-1+Chemotherapy
IMRT
IMRT for primary lesion
Arms:
SBRT+LDRT+PD-1+Chemotherapy
Size
148
Primary endpoint
Progression-free survival
up to 12 months
Eligibility criteria
Inclusion Criteria:
* Diagnosed as recurrence/metastatic NPC
* Histopathological diagnosis of NPC(WHO II/III)
* ECOG 0-1 point
* No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy and chemoradiotherapy;
* At least one lesion 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 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 148, 'type': 'ESTIMATED'}}
Updated at
2024-03-21
1 organization
3 drugs
1 indication
Organization
Sun Yat-sen UniversityDrug
PD-1 antibodyIndication
Nasopharyngeal CarcinomaDrug
GemcitabineDrug
Cisplatin