Adults 18 to 70, any sex, with Oral Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathologic Response.Primary· 8 weeks.
Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. Hematoxylin and eosin (H\&E)-stained slides of entire tumor and all sampled lymph nodes were scanned and assessed by two independent pathologists. The entire tumor bed and all sampled lymph nodes were examined histologically in patients who had pathological complete response (pCR), which was defined as the absence of viable tumor in all slides. MPR was defined as the presence of 10% or less viable residual tumor in the resected tumor specimens.
Group
Value
95% CI
Neoadjuvant PD-1 Blockade Alone
25
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
2
Neoadjuvant PD-1 Blockade Alone
4
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
4
Neoadjuvant PD-1 Blockade Alone
5
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
26
Neoadjuvant PD-1 Blockade Alone
0
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
2
Radiographic Response.Secondary· 8 weeks.
Radiographic response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy were evaluated by enhanced computed tomography examinations and defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete Response (CR) was defined as disappearance of all target lesions. Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions. Stable disease (SD) was defined as \<20% increase and \<30% decrease in the sum of the longest diameter of target lesions. Progressi
Group
Value
95% CI
Neoadjuvant PD-1 Blockade Alone
0
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
0
Neoadjuvant PD-1 Blockade Alone
3
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
16
Neoadjuvant PD-1 Blockade Alone
20
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
14
Neoadjuvant PD-1 Blockade Alone
11
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
1
Adverse events — posted to ClinicalTrials.gov
Time frame: The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Neoadjuvant PD-1 Blockade Alone
Serious: 2/34 (6%)
Deaths: 0/34
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other Hospital of Stomatology, Wuhan University trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospital of Stomatology, Wuhan University
Last refreshed: 10 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04649476.