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

NCT ID: NCT06323239

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2028-07-01

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

SBRT for metastatic lesions

Low-dose Radiotherapy (LDRT)

Intervention Type: RADIATION

LDRT for metastatic lesions

Toripalimab

Intervention Type: DRUG

6 cycles for combined therapy. Toripalimab maintenance for 1 year.

Gemcitabine

Intervention Type: DRUG

6 cycles for combined therapy.

Cisplatin

Intervention Type: DRUG

6 cycles for combined therapy.

IMRT

Intervention Type: RADIATION

IMRT for primary lesion

Interventions

SBRT

SBRT for metastatic lesions

Intervention Type: RADIATION

Low-dose Radiotherapy (LDRT)

LDRT for metastatic lesions

Intervention Type: RADIATION

Toripalimab

6 cycles for combined therapy. Toripalimab maintenance for 1 year.

Intervention Type: DRUG

Gemcitabine

6 cycles for combined therapy.

Intervention Type: DRUG

Cisplatin

6 cycles for combined therapy.

Intervention Type: DRUG

IMRT

IMRT for primary lesion

Intervention Type: RADIATION

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.

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

Sponsors

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

Site Status: RECRUITING

Countries

China

Central Contacts

Jingjing Miao, MD.

Role: CONTACT

miaojj@sysucc.org.cn

13631355201

Chong Zhao, MD. PhD.

Role: CONTACT

zhaochong@sysucc.org.cn

+8687342638

Facility Contacts

Chong Zhao, M.D

Role: primary

zhaochong@sysucc.org.cn

02087342638

Jingjing Miao, M.D.

Role: backup

miaojj@sysucc.org.cn

13631355201

Other Identifiers

SBRT/LDRT+PD-1+GP for r/mNPC

Identifier Type: -

Identifier Source: org_study_id