Health Trials

A Multicenter, Prospective, Phase II Study of TROP-2 ADC in Combination With Toripalimab for Resectable Locally Advanced Oral Squamous Cell Carcinoma

ConditionOral Squamous Cell Carcinoma (OSCC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai East Hospital

About this trial

This study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or chemoradiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18-75 (inclusive); no gender restrictions.

Histologically or cytologically confirmed locally advanced oral squamous cell carcinoma (AJCC 8th Edition stages III-IVA).

Resectable and having not previously received any antitumor therapy for oral squamous cell carcinoma.

At least one evaluable tumor lesion according to RECIST version 1.1.

Disqualifiers

Presence of precancerous lesions such as oral leukoplakia, erythroplakia, or lichen planus.

History of head and neck radiation therapy.

History of allogeneic hematopoietic stem cell transplantation or organ transplantation.

Received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration of the study drug.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab

    Drug

    Sacituzumab Govitecan(10 mg/kg, intravenous infusion, on Days 1 and 8) in combination with toripalimab (240 mg, intravenous infusion, on Day 1) every 3 weeks, for 2 cycles. OR Sacituzumab Tirumotecan (5 mg/kg, intravenous infusion, on Day 1) in combination with toripalimab (3 mg/kg, intravenous infusion, on Day 1) every 2 weeks, for 3 cycles.

  • Radical Surgery for OSCC

    Procedure/Surgery

    If imaging studies following neoadjuvant therapy show a tumor response of PR or SD, or PD but the tumor is amenable to curative resection, surgery is performed.

  • Radiation Therapy

    Radiation

    Participants will begin adjuvant radiation therapy 4-6 weeks after surgery. Radiation therapy will be administered using intensity-modulated radiation therapy (IMRT) at a dose of 66-70 Gy (investigators may adjust the dose appropriately based on the patient's actual condition).

  • Cisplatin

    Drug

    Participants with high-risk factors, such as extracapsular lymph node invasion or inadequate surgical margins, should receive concurrent cisplatin therapy (unless the investigator determines that the patient is not suitable for cisplatin treatment). The cisplatin regimen includes a 3-week schedule (100 mg/m², at least 2 cycles) or a weekly schedule (40 mg/m², at least 5 cycles), as determined by the investigator based on the patient's individual condition.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

MPR rate

Time frame
in 4 weeks post surgery

Secondary outcomes

1

Incidence and frequency of AEs and SAEs

Time frame
From first dose to 30 days after the last dose of study drug.
2

pCR

Time frame
in 4 weeks post surgery
3

ORR

Time frame
2 years post surgery
4

EFS

Time frame
2 years post surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Huashan Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: