SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: SBRT; Radiation: Low-dose Radiotherapy (LDRT); Drug: Toripalimab; Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jingjing Miao, MD.; Phone Number: 13631355201; Email: miaojj@sysucc.org.cn
• Study Contact Backup: Name: Chong Zhao, MD. PhD.; Phone Number: +8687342638; Email: zhaochong@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Chong Zhao, M.D; Phone Number: 02087342638; Email: zhaochong@sysucc.org.cn
      • Contact: Jingjing Miao, M.D.; Phone Number: 13631355201; Email: miaojj@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT+LDRT+PD-1+Chemotherapy; Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.	Radiation: SBRT; SBRT for metastatic lesions; Radiation: Low-dose Radiotherapy (LDRT); LDRT for metastatic lesions; Drug: Toripalimab; 6 cycles for combined therapy. Toripalimab maintenance for 1 year.; Drug: Gemcitabine; 6 cycles for combined therapy.; Drug: Cisplatin; 6 cycles for combined therapy.; Radiation: IMRT; IMRT for primary lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Defined as the time from randomization to death from any cause.	up to 12 months
Objective Response Rate	The percentage of patients with CR and PR assessed according to RECIST v1.1.	up to 12 months
Disease Control Rate	The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.	up to 12 months
Adverse Events	All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03	up to 12 months
QoL	Assessed by EQ-5D-5L questionnaire	up to 12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Chong Zhao, MD. PhD., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chemotherapy; SBRT; PD-1 antibody; Low-dose radiotherapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Cisplatin; Radiotherapy; toripalimab
• Other Study ID Numbers: SBRT/LDRT+PD-1+GP for r/mNPC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No