Trial · NCT04649476

Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

NCT04649476, Phase 2, Completed, Hospital of Stomatology, Wuhan University; results first posted 2024-04-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma. Trials, record NCT04649476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04649476

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma
NCT number: NCT04649476
Status: Completed
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: Hospital of Stomatology, Wuhan University
Conditions: Oral Squamous Cell Carcinoma
Interventions: Camrelizumab, Camrelizumanb plus TPF
First posted: 2020-12-02
Last updated: 2025-01-10
Results first posted: 2024-04-12

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathologic Response.	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. Pathological partial response (pPR) was defined as presence of more than 10% and less than 50% viable residual tumor and pathological non-response (pNR) was defined as presence of more than 50% viable residual tumor in the resected tumor specimens. Pathologic response was defined as sum of pCR and MPR.
Secondary	Radiographic Response.	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. Progressive disease (PD) was defined as \>=20% increase in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
Secondary	Event-free Survival (EFS) Rate on Each Treatment Arm.	24 months.	EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.
Secondary	Overall Survival (OS) on Each Treatment Arm.	24 months.	OS is the time from randomization to death due to any cause.
Secondary	Adverse Events (AEs).	24 months.	Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions.
Other	Changes in the Level of Circualting Exosomal PD-L1.	24 months.	The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Pathologic Response.	8 weeks.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Radiographic Response.	8 weeks.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event-free Survival (EFS) Rate on Each Treatment Arm.	24 months.
SECONDARY	Overall Survival (OS) on Each Treatment Arm.	24 months.
SECONDARY	Adverse Events (AEs).	24 months.
OTHER_PRE_SPECIFIED	Changes in the Level of Circualting Exosomal PD-L1.	24 months.

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Pathologic Response.	Neoadjuvant PD-1 Blockade Alone	Number of participants who had no response	25	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	Number of participants who had no response	2	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Alone	Number of participants who had partial response	4	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	Number of participants who had partial response	4	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Alone	Number of Participants Pathologic response (pCR+MPR)	5	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	Number of Participants Pathologic response (pCR+MPR)	26	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Alone	Non-evaluable	0	Participants
Pathologic Response.	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	Non-evaluable	2	Participants
Radiographic Response.	Neoadjuvant PD-1 Blockade Alone	CR (Complete response)	0	Participants
Radiographic Response.	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	CR (Complete response)	0	Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Neoadjuvant PD-1 Blockade Alone	34
Overall Study	STARTED	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	34
Overall Study	COMPLETED	Neoadjuvant PD-1 Blockade Alone	34
Overall Study	COMPLETED	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	32
Overall Study	NOT COMPLETED	Neoadjuvant PD-1 Blockade Alone	0
Overall Study	NOT COMPLETED	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	2

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Reactive cutaneous capillary endothelial proliferation, RCCEP	Skin and subcutaneous tissue disorders	Neoadjuvant PD-1 Blockade Alone	29	34	29
other	Reactive cutaneous capillary endothelial proliferation, RCCEP	Skin and subcutaneous tissue disorders	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	24	34	24
other	Anemia	Blood and lymphatic system disorders	Neoadjuvant PD-1 Blockade Alone	7	34	7
other	Anemia	Blood and lymphatic system disorders	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	25	34	25
other	Mucositis oral	Skin and subcutaneous tissue disorders	Neoadjuvant PD-1 Blockade Alone	6	34	6
other	Mucositis oral	Skin and subcutaneous tissue disorders	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	8	34	8
other	Creatinine increased	Renal and urinary disorders	Neoadjuvant PD-1 Blockade Alone	6	34	6
other	Creatinine increased	Renal and urinary disorders	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	15	34	15
other	GGT increased	Hepatobiliary disorders	Neoadjuvant PD-1 Blockade Alone	4	34	4
other	GGT increased	Hepatobiliary disorders	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	5	34	5

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Neoadjuvant PD-1 Blockade Alone	0	34
Total, all-cause mortality	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	1	34
Total, other adverse events	Neoadjuvant PD-1 Blockade Alone	34	34
Total, other adverse events	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	34	34
Total, serious adverse events	Neoadjuvant PD-1 Blockade Alone	2	34
Total, serious adverse events	Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy	11	34

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39889711	DERIVED	PubMed
40107247	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Neoadjuvant PD-1 Blockade Alone vs Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy: deaths from any cause	Trial comparisons
Neoadjuvant PD-1 Blockade Alone vs Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04649476

GET https://conductscience.org/api/trials/v1/NCT04649476/events?page=2

API reference For AI assistants