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

NCT ID: NCT06323239

Condition: Nasopharyngeal Carcinoma

Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine

Conditions: Keywords:
SBRT
Low-dose radiotherapy
PD-1 antibody
Chemotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: SBRT
Description: SBRT for metastatic lesions
Arm group label: SBRT+LDRT+PD-1+Chemotherapy

Intervention type: Radiation
Intervention name: Low-dose Radiotherapy (LDRT)
Description: LDRT for metastatic lesions
Arm group label: SBRT+LDRT+PD-1+Chemotherapy

Intervention type: Drug
Intervention name: Toripalimab
Description: 6 cycles for combined therapy. Toripalimab maintenance for 1 year.
Arm group label: SBRT+LDRT+PD-1+Chemotherapy

Intervention type: Drug
Intervention name: Gemcitabine
Description: 6 cycles for combined therapy.
Arm group label: SBRT+LDRT+PD-1+Chemotherapy

Intervention type: Drug
Intervention name: Cisplatin
Description: 6 cycles for combined therapy.
Arm group label: SBRT+LDRT+PD-1+Chemotherapy

Intervention type: Radiation
Intervention name: IMRT
Description: IMRT for primary lesion
Arm group label: SBRT+LDRT+PD-1+Chemotherapy

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Chong Zhao, M.D

Phone: 02087342638
Email: zhaochong@sysucc.org.cn

Contact backup:
Last name: Jingjing Miao, M.D.

Phone: 13631355201
Email: miaojj@sysucc.org.cn

Start date: July 15, 2024

Completion date: July 1, 2028

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06323239

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