SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma

NCT ID: NCT05524168

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2026-12-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT+PD-1+Chemotherapy

Patients will receive SBRT first, then PD-1 antibody (Camrelizumab 200mg/Q3W) and chemotherapy (cisplatin 80mg/m2 on d1, gemcitabine 1000mg/m2, d1 and d8, Q3W, maximum 6 cycles), followed by Camrelizumab (200mg/Q3W) until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 1 year treatment.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

SBRT for metastatic lesions

Camrelizumab

Intervention Type: DRUG

Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.

Gemcitabine

Intervention Type: DRUG

Maximum 6 cycles for combined therapy.

Cisplatin

Intervention Type: DRUG

Maximum 6 cycles for combined therapy.

Interventions

SBRT

SBRT for metastatic lesions

Intervention Type: RADIATION

Camrelizumab

Maximum 6 cycles for combined therapy. Camrelizumab maintenance for 1 year.

Intervention Type: DRUG

Gemcitabine

Maximum 6 cycles for combined therapy.

Intervention Type: DRUG

Cisplatin

Maximum 6 cycles for combined therapy.

Intervention Type: DRUG

Other Intervention Names

SHR-1210

Eligibility Criteria

Inclusion Criteria

• Diagnosed as metastatic NPC with no more than 5 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Chongqing University Cancer Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhao Chong

Dr. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chong Zhao, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SBRT+PD-1+Chemo for mNPC

Identifier Type: -

Identifier Source: org_study_id