PhII Study of Toripalimab Followed by Definitive CRT & Adjuvant Toripalimab in Locally Advanced ESCC

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT07836049
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab — DRUG
    Injection Q3W at 240mg doses
  • Carboplatin + Paclitaxel — DRUG
    Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2

Study Details

This is a phase 2/window of opportunity study to determine the efficacy, by clinical complete response, and safety of induction toripalimab (PD-1 inhibitor) followed by definitive chemoradiotherapy (dCRT) and adjuvant toripalimab (up to one year) in patients with stage II - IVA ESCC. Tumor biopsies (tumor tissue, adjacent normal tissue), blood including ctDNA, and saliva will be obtained before, during, and after the induction phase. These tissues will be assessed for clinical and research associated markers and processes that may provide information regarding the role of toripalimab in tumor related processes.

Key Dates

First listed
Sep 23, 2026
Start date
Dec 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Toripalimab + CRT
    Intravenous (IV) toripalimab infusions on Day 1 of each 21-day treatment cycle for 2 doses prior to dCRT followed by adjuvant toripalimab for up to 1 year. No toripalimab will be given during SOC dCRT. After dCRT, all patients can progress to adjuvant toripalimab or resection followed by adjuvant toripalimab. After adjuvant toripalimab, routine surveillance will involve serial esophagogastroduodenoscopies (EGDs) and imaging. Treatment will continue for up to an additional year with adjuvant toripalimab infusions, until disease progression, or intolerable toxicity. Patients will be followed for OS and subsequent anticancer therapy for up to 3 years after ending study treatment. Note: Toripalimab will be provided to the study by Coherus. Each site will obtain carboplatin and paclitaxel from commercial supply to administer as standard of care.

Primary Outcome Measure

To determine the clinical complete response rate to proportion of patients with complete clinical response (cCR) 4-12 weeks after completion of standard-of-care (SOC) dCRT. [ Time Frame: 4-11 weeks after completion of standard-of-care (SOC) dCRT. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Michael Gibson (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Vanderbilt University Medical Center· Nashville, TN

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