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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323239
• Other study ID #: SBRT/LDRT+PD-1+GP for r/mNPC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Jingjing Miao, MD.
• Phone: 13631355201
• Email: miaojj[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 148
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• SBRT
SBRT for metastatic lesions
• Low-dose Radiotherapy (LDRT)
LDRT for metastatic lesions

Drug:
• Toripalimab
6 cycles for combined therapy. Toripalimab maintenance for 1 year.
• Gemcitabine
6 cycles for combined therapy.
• Cisplatin
6 cycles for combined therapy.

Radiation:
• IMRT
IMRT for primary lesion

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	Defined as the time from randomization to death from any cause.	up to 12 months
Secondary	Objective Response Rate	The percentage of patients with CR and PR assessed according to RECIST v1.1.	up to 12 months
Secondary	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
Secondary	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
Secondary	QoL	Assessed by EQ-5D-5L questionnaire	up to 12 months