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

NCT07778368 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-21

No results posted yet for this study

Summary

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.

Conditions

  • Oral Squamous Cell Carcinoma (OSCC)

Interventions

DRUG

Sacituzumab Govitecan OR Sacituzumab Tirumotecan in Combination with Toripalimab

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.

PROCEDURE

Radical Surgery for OSCC

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

Radiation Therapy

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).

DRUG

Cisplatin

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • Shanghai East Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-08-31
Completion
2029-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778368 on ClinicalTrials.gov