Combining targeted therapy and chemotherapy for advanced nasopharyngeal cancer

SBRT Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Nasopharyngeal Carcinoma With Oligometastasis: A Prospective, Multicenter, Single-arm, Phase II Clinical Trial

This study is testing a new treatment that combines radiation therapy, a specific antibody, and chemotherapy to see if it helps people with advanced nasopharyngeal cancer who have a few metastatic spots and haven't had other treatments before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (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: NCT05524168 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm, phase II clinical trial aims to evaluate the effectiveness and safety of stereotactic body radiation therapy (SBRT) combined with a PD-1 antibody (Camrelizumab) and chemotherapy (Gemcitabine and Cisplatin) in patients with oligometastatic nasopharyngeal carcinoma. The study focuses on patients who have a limited number of metastatic lesions and have not received prior systemic treatments. Participants will undergo SBRT targeting their metastatic lesions while receiving the PD-1 antibody and chemotherapy to assess the combined treatment's efficacy and adverse effects.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with metastatic nasopharyngeal carcinoma with no more than three metastatic lesions and who have not undergone prior systemic treatments.

Not a fit: Patients with multiple metastatic lesions or those who have previously received systemic treatments 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 oligometastatic nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in various cancers, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Diagnosed as metastatic NPC with no more than 3 metastatic lesions;
* Histopathological diagnosis of NPC;
* ECOG 0-1 point;
* Has not received prior systemic treatment, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy and chemoradiotherapy;
* Every metastatic lesions 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 previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
* 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; PD-1 antibody; Chemotherapy; Efficacy; Safety; Oligometastasis