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Esophageal Squamous Cell CarcinomaPhase 2NCT06588335

BTLA Inhibitor (JS004) Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

A Phase 2 study testing BTLA inhibitor (JS004), Toripalimab and Paclitaxel, Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Henan Provincial People's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, single-arm, phase II study, aiming to preliminarily explore the efficacy and safety of JS004 combined with toripalimab and chemotherapy for perioperative treatment of locally advanced thoracic esophageal squamous cell carcinoma that is resectable. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
BTLA inhibitor (JS004), Toripalimab and Paclitaxel, Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
30 Sep 2024to 30 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up;
  • Age 18-75 years old, including 18 and 75 years old, both male and female;
  • Histologically or cytologically confirmed clinical stage of locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging);
  • Enhanced CT of the neck shows no suspicious metastatic lymph nodes (excluding lymph nodes in the esophageal cancer area), and imaging examination shows no distant metastasis;
  • ECOG: 0~1 score;
  • Expected to achieve R0 resection;
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  • No previous anti-tumor treatment for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy and immunotherapy;
  • Have measurable lesions or assessable non-measurable lesions (according to RECIST 1.1 criteria);
  • The function of important organs meets the following requirements (no use of any blood components and cell growth factors is allowed within 2 weeks before the screening examination): a. Absolute neutrophil count (ANC) ≥1.5×10^9/L; b. Platelets ≥100×10^9/L; c. Hemoglobin ≥90g/dL; d. Serum albumin ≥2.8g/dL; e. Total bilirubin ≤1.5×ULN, ALT, AST and/or AKP ≤2.5×ULN; f. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60mL/min (calculated by Cockcroft-Gault formula); g. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN (for those using a stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin, and the INR is within the expected therapeutic range of the anticoagulant, they can be screened);
  • For female subjects of childbearing potential, a urine or serum pregnancy test must be performed within 72 hours prior to receiving the first study drug, and the result must be negative, and they are willing to use effective contraception during the study period and for 6 months after the last dose.

Who cannot join

  • Patients at high risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
  • Patients with uncontrolled, recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Patients with severe dysfunction of the heart, lung, liver, kidney, hematopoietic system, endocrine system, or cachexia.
  • Patients who have received any of the following treatments: a. Major surgery (except for diagnostic tissue biopsy) or serious trauma within 4 weeks prior to first study drug administration. b. Anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biotherapy, or tumor embolization) within 4 weeks prior to first study drug administration. c. Any investigational drug within 4 weeks prior to first study drug administration. d. Anti-cancer vaccine or live vaccine within 4 weeks prior to first study drug administration. e. Systemic corticosteroid therapy (>10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to first study drug administration, except for local inflammation of the esophagus and prevention of allergy and nausea/vomiting.
  • Patients whose previous anti-cancer therapy toxicity has not recovered to ≤CTCAE Grade 1 (except for alopecia).
  • Patients with sodium, potassium, or calcium laboratory abnormalities >Grade 1 that cannot be corrected within 2 weeks prior to first study drug administration.
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  • Patients with any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism), except for vitiligo or childhood asthma/allergy that has resolved without the need for intervention in adulthood.
  • Patients with a history of immunodeficiency, including HIV-positive, other acquired or congenital immunodeficiency disorders, organ transplant, or allogeneic bone marrow transplant.
  • Patients with uncontrolled cardiac conditions, such as (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, or (4) clinically significant arrhythmias requiring intervention.
  • Patients with a serious infection (CTCAE >Grade 2) within 4 weeks prior to first study drug administration, active lung inflammation on baseline imaging, or symptoms/signs of infection within 2 weeks prior to first study drug administration requiring oral or IV antibiotics (except for prophylactic use).
  • Patients with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) or active hepatitis C (positive HCV antibody and detectable HCV-RNA).
  • Patients with known hypersensitivity, allergy, or contraindication to JS004, toripalimab, or any of their formulation components.
  • Patients with any other malignancy, except for low-risk malignancies (5-year survival rate >90%) such as fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
  • Pregnant or breastfeeding women, or patients of reproductive potential unwilling or unable to use effective contraception.
  • The investigator may also exclude patients if there are other factors that may lead to premature discontinuation from the study, such as other serious concurrent illnesses (including psychiatric disorders) requiring concomitant treatment, high risk of recurrence of recent serious illness (e.g., myocardial infarction, stroke), severe laboratory abnormalities, or family/social factors that may affect patient safety or data collection.

Trial locations and contacts

No sites are listed yet.

LI WEI contact

13837170909

wlixxt@163.com

About this study

Official title: A Single-Center, Exploratory Study of BTLA Inhibitor (JS004) Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

This is a single-center, single-arm, phase II study, aiming to preliminarily explore the efficacy and safety of JS004 combined with toripalimab and chemotherapy for perioperative treatment of locally advanced thoracic esophageal squamous cell carcinoma that is resectable. The plan is to enroll 20 patients with locally advanced resectable thoracic esophageal cancer. In the neoadjuvant treatment phase, patients will receive JS004 + toripalimab + chemotherapy (paclitaxel + cisplatin) for 2 cycles. This will be followed by the surgical phase: surgery will be performed 3-8 weeks after the last dose of neoadjuvant treatment. In the postoperative maintenance treatment phase, maintenance treatment will start 4 weeks ± 7 days after surgery, but no later than 10 weeks after surgery. For patients with R0 resection confirmed by postoperative pathology, they will receive maintenance treatment with JS004 + toripalimab for up to 15 cycles. For patients with non-R0 resection, they will receive maintenance treatment with JS004 + toripalimab combined with standard radiation or chemotherapy (selected by the investigator based on esophageal cancer guidelines). During the study, the maximum number of cycles of JS004 combined with toripalimab is 17 cycles (approximately 1 year).

Being tested
BTLA inhibitor (JS004), Toripalimab, Paclitaxel, Cisplatin
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.

  • BTLA inhibitor (JS004)Drug

    BTLA inhibitor (JS004):200mg, intravenous infusion , d1, Q3W;

  • ToripalimabDrug

    Toripalimab:240mg,intravenous infusion, d1, Q3W;

  • Paclitaxel, CisplatinDrug

    Paclitaxel, 175mg/m2, intravenous infusion, d1, Q3W; Cisplatin, 75mg/m2, intravenous infusion, d1, Q3W;

Study groups in NCT06588335
Study groupRoleWhat they receive
S004+ Toripalimb+Chemotherapy (paclitaxel + cisplatin)ExperimentalNeoadjuvant therapy stage: JS004+ triplizumab + chemotherapy (paclitaxel + cisplatin), 2 cycles; Operation stage: Surgery 3-8 weeks after the last neoadjuvant; Postoperative maintenance treatment stage: Maintenance therapy was started at 4 weeks ±7 days after surgery. Postoperative maintenance therapy should be initiated no later than 10 weeks after surgery.
Receives: Drug: BTLA inhibitor (JS004); Drug: Toripalimab; Drug: Paclitaxel, Cisplatin

What is being measured

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

  1. Pathological complete response rate (pCR)

    pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.assessment criteria after neoadjuvant therapy, as defined by the CAP (College of American Pathologists) and NCCN (National Comprehensive Cancer Network) guidelines.

    Measured: up to 3 weeks after neoadjuvant

Secondary outcomes (3)

  1. Major pathological response rate (MPR)

    mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy

    Measured: up to 3 weeks after neoadjuvant

  2. Event-free lifetime (EFS)

    EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by central pathologist or by imaging using RECIST 1.1 assessed by investigator

    Measured: up to 3 years

  3. Overall survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: 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 posted19 Sep 2024
  2. Study start30 Sep 2024 (estimated)
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2026 (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
NCT06588335
Sponsor's protocol ID
HenanPPH-WEILI
Status last verified
Sep 2024
First submitted
5 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BTLA inhibitor (JS004), Toripalimab and Paclitaxel, Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Henan Provincial People's Hospital.

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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact LI WEI (13837170909, wlixxt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (pCR) (time frame: up to 3 weeks after neoadjuvant). 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 NCT06588335.

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 19 Sep 2024.

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