Not Yet RecruitingNot Applicable

Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma

China85 participantsStarted 2026-04-01

Plain-language summary

Neoadjuvant immunochemotherapy (NAIC) has demonstrated promising pathological and survival outcomes in patients with resectable locally advanced oral and oropharyngeal squamous cell carcinoma (LA-OSCC/OPSCC). However, the optimal postoperative management strategy following NAIC and radical surgery remains undefined, particularly regarding the necessity of postoperative radiotherapy and the potential role of PD-1 inhibitor maintenance therapy. This single-center, ambispective cohort study aims to compare event-free survival, pathological response, survival outcomes, failure patterns, treatment-related toxicities, and functional outcomes among three postoperative strategies: postoperative radiotherapy, postoperative PD-1 inhibitor maintenance, and observation alone. The study seeks to provide real-world evidence to support risk-adapted, individualized postoperative decision-making after NAIC

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18-80 years, any gender.
✓. Expected survival ≥ 6 months.
✓. Adequate major organ function; ECOG performance status 0-1.
✓. Treatment-naïve patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC), in accordance with the 8th edition of the American Joint Committee on Cancer (AJCC) staging system (2017) and the 2020 Chinese Stomatological Association (CSA) guidelines for pathological diagnosis of oral and oropharyngeal cancers, with clinical stages: cT3N0M0, cT1-3N1M0, cT4aN0-2M0, cT1-4aN3M0, or cT4bN0-3M0.
✓. No evidence of distant metastasis based on auxiliary examinations.
✓. No prior antitumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapies.
✓. Received 2 cycles of neoadjuvant chemoimmunotherapy (toripalimab + TP regimen) and underwent R0 resection.
✓. Women of childbearing potential must agree to use effective contraception during treatment and for 3 months after.

Exclusion criteria

What they're measuring

1-Year Event-Free Survival (EFS)

Timeframe: 1-Year

Pathological Complete Response (pCR) Rate

Timeframe: At the time of surgery

Trial details

NCT IDNCT07457099

SponsorZhujiang Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-30

Contact for this trial

Xiaozhi LV

02062783160 lxzsurgeon@126.com

View on ClinicalTrials.gov More Locally Advanced Oral Squamous Cell Carcinoma trials