The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHospital of Stomatology, Wuhan University

About this trial

The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are:

• \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.\].

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Oral squamous cell carcinoma patients diagnosed by histology or cytology;

Has not received any treatment for oral squamous cell carcinoma in the past;

According to the AJCC TNM staging system, stage clinical IVB;

ECOG score: 0-1 points;

Disqualifiers

There are uncontrollable pleural effusion, pericardial effusion, or abdominal effusion that require repeated drainage;

Have a history of allergies to any components of adelbizumab in the past;

Received any other investigational medication within 4 weeks prior to the first use of the investigational medication, or had a half-life of no more than 5 weeks from the last investigational medication;

Simultaneously enroll in another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab:20mg/kg, ivdrip, D1,Q3W

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effective mitigation rate(EMR)

Pathological complete remission(PCR)+Major pathological relief(MPR)

Time frame
From enrollment to the end of surgery,assessed up to 6 months

Secondary outcomes

1

DFS

Disease free survival

Time frame
From enrollment to the first appearance of disease progression or date of death from any cause,whichever came first, assessed up to 36 months
2

R0 resection rate

:R0 is the ratio of no residue under the microscope after resection

Time frame
From enrollment to the end of surgery,whichever came first, assessed up to 6 months
3

ORR

Objective response rate

Time frame
From enrollment to initial efficacy evaluation,assessed up to 6 months
4

mOS

Median overall survival

Time frame
From enrollment to patient death,assessed up to 50 months

Other outcomes

Sponsors and contacts

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