Comparing two surgical approaches for recurrent nasopharyngeal carcinoma after chemotherapy

Reduced-target Resection Compared With Full-target Resection After Induction Chemotherapy in Resectable Recurrent Nasopharyngeal Carcinoma: a Multicentre, Randomised, Open-label, Phase 3 Trial

This study is testing whether a less extensive surgery for recurrent nasopharyngeal cancer after chemotherapy can be just as effective as a more extensive surgery while reducing risks for patients.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Apatinib, chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05877872 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of reduced-target resection versus full-target resection in patients with resectable recurrent nasopharyngeal carcinoma following induction chemotherapy. Participants will be randomly assigned to one of the two surgical approaches to determine if the reduced-target method is as effective as the full-target method while minimizing surgical risks. The study will also incorporate adjuvant immunotherapy to address any residual tumor lesions. By assessing the outcomes, the trial seeks to establish a safer surgical option without compromising patient survival.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed recurrent nasopharyngeal carcinoma who are resectable and have not experienced recurrence within six months post-radiotherapy.

Not a fit: Patients with unresectable tumors or those who have had recurrence within six months of radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less invasive surgeries for patients with recurrent nasopharyngeal carcinoma, reducing surgical risks and complications.

How similar studies have performed: Other studies have explored similar de-escalation strategies in cancer treatment, showing promising results, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. The recurrence time is more than 6 months from the end of radiotherapy.
2. Histologically confirmed recurrent nasopharyngeal carcinoma.
3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus) (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma). If the tumor invaded the internal carotid artery, or the instance from the internal carotid artery was less than 0.5cm, but the invasion area did not exceed the external edge of the internal carotid artery, the patients could be enrolled after internal carotid artery pretreatment (including internal carotid artery embolization or stent implantation).
4. After 3 cycles induction chemotherapy (Platinum based chemotherapy \[gemcitabine/paclitaxel and platinum\] and immunotherapy\[PD-1/PD-L1 antibody\] or a GAP regmen\[gemcitabine, Apatinib and immunotherapy\[PD-1/PD-L1 antibody\]), patients achieved at least PR according to RECIST criteria, and the reduction of pSTV after induction chemotherapy more than 50%.
5. Given written informed consent.

Exclusion Criteria:

1. Karnofsky Performance Status (KPS) ≤70.
2. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
3. Tumor confined to the roof or the posterior wall of nasopharynx, without expected benefit from reduced-target resection.
4. Unresectable recurrent regional lymph node diseases (recurrent N1-3) with prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement (according to the 8th edition of AJCC staging system).
5. Clinically diagnosed with metastatic NPC.
6. Has known subjects with other malignant tumors (except for cured skin basal cell carcinoma or cervical carcinoma in situ).
7. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
8. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.

   Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
9. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
10. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
11. Has received a live vaccine within 4 weeks of planned start of study treatment. Pregnancy or breast feeding.
12. Cannot complete regular follow-up.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Principal investigator: Ming-Yuan Chen, MD, PhD — Sun Yat-sen University
• Study coordinator: Ming-Yuan Chen, MD, PhD

Conditions Nasopharyngeal Carcinoma; De-escaltion Therapy