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

NCT06323239 | Recruiting Phase 2 DMC

• 1 other identifier: SBRT/LDRT+PD-1+GP for r/mNPC
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Keywords

SBRT; Low-dose radiotherapy; PD-1 antibody; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival

  up to 12 months

• Objective Response Rate

  up to 12 months

• Disease Control Rate

  up to 12 months

• Adverse Events

  up to 12 months

• QoL

  up to 12 months

Study Arms (1)

SBRT+LDRT+PD-1+Chemotherapy

EXPERIMENTAL

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; Radiation: Low-dose Radiotherapy (LDRT); Drug: Toripalimab; Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT

Interventions

SBRT RADIATION

SBRT for metastatic lesions

SBRT+LDRT+PD-1+Chemotherapy

Low-dose Radiotherapy (LDRT) RADIATION

LDRT for metastatic lesions

SBRT+LDRT+PD-1+Chemotherapy

Toripalimab DRUG

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

SBRT+LDRT+PD-1+Chemotherapy

Gemcitabine DRUG

6 cycles for combined therapy.

SBRT+LDRT+PD-1+Chemotherapy

Cisplatin DRUG

6 cycles for combined therapy.

SBRT+LDRT+PD-1+Chemotherapy

IMRT RADIATION

IMRT for primary lesion

SBRT+LDRT+PD-1+Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy; toripalimab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Chong Zhao, MD. PhD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Miao, MD.

CONTACT

13631355201; miaojj@sysucc.org.cn

Chong Zhao, MD. PhD.

CONTACT

+8687342638; zhaochong@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Prof.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CN (1)