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Esophageal Squamous Cell CarcinomaPhase 2NCT07836049

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

A Phase 2 study testing Toripalimab and Carboplatin + Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Toripalimab and Carboplatin + Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
31 Dec 2026to 31 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated written informed consent.
  • Age ≥ 18 years the day of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Previously untreated, resectable, histologically confirmed stage II-IVA esophageal squamous cell carcinoma according to the 8th TNM staging system of the American Joint Committee on Cancer.
  • Has provided archival or newly obtained core or excisional biopsy tissue (fine needle aspirate [FNA] is not adequate) of a tumor lesion for local standard of care biomarker analysis. Repeat samples may be required if adequate tissue is not provided. Note: Formalin-fixed, paraffin embedded tissue blocks are preferred to slides.
  • Adequate organ and bone marrow function resulted ≤ 28 days prior to first dose of protocol-indicated treatment:
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  • Absolute neutrophil count (ANC) ≥ 1500/µL.
  • Platelets ≥ 100,000/µL.
  • Hemoglobin ≥ 7.0 g/dL
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (as calculated by the Cockcroft-Gault Formula or calculated/measured by an alternative established institutional standard consistently applied across participants at the site) or serum creatinine ≤ 1.5x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times institutional ULN
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional ULN.
  • Serum albumin ≥ 2.8 g/dL

Who cannot join

  • Locally advanced and incurable or metastatic disease is deemed incurable.
  • History of another malignancy within 3 years prior to screening, except for non-melanoma skin carcinoma, low-grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the cervix, or stage I uterine cancer.
  • Multiple primary esophageal cancers.
  • Previous radiotherapy of the thorax.
  • Previous immune checkpoint inhibitor therapy (including agents targeting PD-1, PD-L1/PD-L2, CTLA-4, LAG-3, TIGIT).
  • Active autoimmune disease, solid organ transplant recipient, or prednisone dose (or a steroid equivalent) of more than 10mg daily.
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  • Previous non-infectious pneumonitis or interstitial lung disease.
  • Any severe comorbidity (e.g. uncontrolled diabetes or decompensated heart failure) which in the determination of the treating physician would preclude the patient from receiving this experimental treatment regimen.
  • Contraindication to ICI or suspected allergy/hypersensitivity to monoclonal antibodies or any ingredients of toripalimab.
  • Known allergy/hypersensitivity to carboplatin or paclitaxel.
  • Inability to provide informed consent due to psychological, familial, social, or other factors.
  • Presence of CTCAEv6 grade ≥ 2 neuropathy.
  • Pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanderbilt-Ingram Services for Timely Access contact

800-811-8480

cip@vumc.org

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Michael Gibson

Other trials in United States

About this study

Official title: A Phase II Study of Induction/Window of Opportunity Toripalimab Followed by Definitive Chemoradiotherapy (CRT) and Adjuvant Toripalimab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

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.

Read the detailed description

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.

Being tested
Toripalimab, Carboplatin + Paclitaxel
Keywords
locally advanced
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Also called Loqtorzi, toripalimab-tpzi

    Injection Q3W at 240mg doses

  • Carboplatin + PaclitaxelDrug

    Also called CarboTaxol, PC

    Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2

Study groups in NCT07836049
Study groupRoleWhat they receive
Toripalimab + CRTExperimentalIntravenous (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.
Receives: Drug: Toripalimab; Drug: Carboplatin + Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Determine cCR score by achieving all of these:1

    • No lesion, budding, or ulceration identified on esophagogastroduodenoscopy (EGD).
    • Bite-on-bite biopsies with no residual tumor.
    • EGD with endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of suspicious lymph nodes (LNs) shows no residual tumor.

    If patients have suspicious LNs unable to be reached by FNA, they will not be classified as clinical complete responders.

    Measured: 4-11 weeks after completion of standard-of-care (SOC) dCRT.

Secondary outcomes (4)

  1. To determine Disease-free survival (DFS

    1, 2, and 3-year disease free survival rates defined as time from the start of treatment until disease recurrence, death from any cause, or the end of the study period if the patient does not experience recurrence.

    Measured: from start of treatment until 1, 2, and 3yrs post treatment

  2. To determine Overall survival (OS)

    2 and 3-year overall survival rates defined as the time from start of treatment until death from any cause, or the end of the study period/last follow up.

    Measured: from start of treatment until 2 and 3yrs post treatment

  3. To determine frequency of Adverse Events (AEs)

    AEs will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6).

    Measured: through study completion, an average of 1 year

  4. To determine Quality of life (QOL) measurements

    The EORTC-QLQ-C30 questionnaire will be administered prior to toripalimab induction (during screening), after induction (post-induction assessment), after dCRT (post-CRT assessment), at EOT visit, and then at coinciding follow-up visits for up to 3 years.

    Uses scores from 0 to 100 for each part; High functional score means good health; High symptom score means high pain or trouble

    Measured: (during screening), after induction (post-induction assessment), after dCRT (post-CRT assessment), at EOT visit, and then at coinciding follow-up visits for up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07836049
Sponsor's protocol ID
VICCGI25-05
Status last verified
Sep 2026
First submitted
13 Aug 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab and Carboplatin + Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07836049.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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