Combining PD-1 antibody with chemoradiotherapy for recurrent nasopharyngeal carcinoma

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial

This study is testing if adding a PD-1 antibody to standard chemoradiotherapy can help people with recurrent nasopharyngeal carcinoma feel better compared to just using chemoradiotherapy alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 12 sites (Guangzhou, Guangdong and 11 other locations)
• Trial ID: NCT03907826 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized controlled phase III clinical trial aims to evaluate the efficacy and adverse effects of a PD-1 antibody in combination with chemoradiotherapy compared to chemoradiotherapy alone in patients with recurrent nasopharyngeal carcinoma. Participants will be monitored for treatment outcomes and side effects to determine the potential benefits of this combined approach. The study includes patients who have experienced local or regional recurrence after radical treatment and are not suitable for surgery.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with local or regional recurrence of nasopharyngeal carcinoma after at least one year post-radical treatment who are not suitable for surgery.

Not a fit: Patients who have received prior treatment for recurrent nasopharyngeal carcinoma or those with severe late toxicities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with recurrent nasopharyngeal carcinoma by enhancing the effectiveness of chemoradiotherapy.

How similar studies have performed: Other studies have shown promising results with similar approaches using PD-1 antibodies in combination with conventional therapies, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
* Not suitable for surgery;
* Newly histologic diagnosis of NPC (WHO II/III);
* Clinical stage rII-IVa (AJCC/UICC 8th);
* ECOG 0-1 point;
* No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy or radiotherapy;
* 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 two months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* Treated with anti-tumor Chinese medicine treatment;
* Have recurrence with local necrosis;
* Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
* Unexplained fever \> 38.5 ℃, except for tumor fever;
* Treated with ≥ 5 days antibiotics one month before enrollment;
* 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 ≥10E4copiers/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 and 11 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Peking University Third Hospital — Beijing, China (Not_yet_recruiting)
• Sichuan Cancer Hospital — Chengdu, China (Not_yet_recruiting)
• Fujian Province Cancer Hospital — Fuzhou, China (Not_yet_recruiting)
• Guizhou Cancer Hospital — Guiyang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Not_yet_recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, China (Recruiting)
• Xijing Hospital — Xi'an, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Chong Zhao — Sun Yat-Sen University Cancer Center
• Study coordinator: Jingjing Miao

Conditions Recurrent Nasopharyngeal Carcinoma; PD-1 antibody; Intensity-modulated Radiation Therapy; Efficacy; Adverse effect; chemotherapy