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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Jingjing Miao, MD.
miaojj@sysucc.org.cn
13631355201
Backup
Chong Zhao, MD. PhD.
zhaochong@sysucc.org.cn
+8687342638
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 148
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials