Combining targeted therapies and chemotherapy for advanced nasopharyngeal carcinoma

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

This study is testing a new treatment that combines targeted therapies and chemotherapy to see if it helps people with advanced nasopharyngeal carcinoma feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06323239 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) with a PD-1 antibody and chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma. It is a single-arm, phase II trial that aims to determine how well this combination works in treating the disease. Participants will receive treatments including Toripalimab, Gemcitabine, and Cisplatin, and their responses will be monitored for efficacy and adverse effects.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with recurrent or metastatic nasopharyngeal carcinoma who have not received prior treatment for their condition.

Not a fit: Patients with allergies to the components of the treatments or those who have received prior therapies for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating various cancers, suggesting potential for success in this approach.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Chong Zhao, MD. PhD. — Sun Yat-sen University
• Study coordinator: Jingjing Miao, MD.

Conditions Nasopharyngeal Carcinoma; SBRT; Low-dose radiotherapy; PD-1 antibody; Chemotherapy