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

NCT05524168 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SBRT+PD-1+Chemo for mNPC
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

SBRT; PD-1 antibody; Chemotherapy; Efficacy; Safety; Oligometastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival

  up to 12 months

• Objective Response Rate

  up to 12 months

• Disease Control Rate

  up to 12 months

• Adverse Events

  up to 12 months

• QoL

  up to 12 months

Study Arms (1)

SBRT+PD-1+Chemotherapy

EXPERIMENTAL

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.

Radiation: SBRT; Drug: Camrelizumab; Drug: Gemcitabine; Drug: Cisplatin

Interventions

SBRT RADIATION

SBRT for metastatic lesions

SBRT+PD-1+Chemotherapy

Camrelizumab DRUG

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

Also known as: SHR-1210

SBRT+PD-1+Chemotherapy

Gemcitabine DRUG

Maximum 6 cycles for combined therapy.

SBRT+PD-1+Chemotherapy

Cisplatin DRUG

Maximum 6 cycles for combined therapy.

SBRT+PD-1+Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Shenzhen People's Hospital: collaborator
• First People's Hospital of Foshan: collaborator
• Jiangxi Provincial Cancer Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Chongqing University Cancer Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Chong Zhao, MD. PhD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Prof.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: November 25, 2022
• Primary Completion: June 6, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)