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Esophageal Squamous Cell CarcinomaPhase 2NCT06637163

Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC

A Phase 2 study testing Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy and Paclitaxel + Carboplatin + Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will explore the efficacy and safety of benmelstobart combined with radiochemotherapy compared to radiochemotherapy alone as neoadjuvant treatment for esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy and Paclitaxel + Carboplatin + Radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
5 sitesChina
Study dates
24 Oct 2024to Apr 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily participate in this study and sign informed consent forms, with good compliance.
  • Aged 18 years and older, regardless of gender.
  • ECOG performance status: 0-1.
  • Patients with histologically confirmed clinical stages T1-3N+M0 or T3NanyM0 of resectable esophageal squamous cell carcinoma.
  • No prior antitumor treatment for esophageal cancer, including chemotherapy, hormone therapy, radiotherapy, or immunotherapy.
  • Laboratory tests must meet the following criteria (within 7 days prior to baseline enrollment):
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  • Complete blood count: a. Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion in the last 14 days); b. Neutrophil count (NEUT) ≥ 1.5 × 10^9/L; c. Platelet count (PLT) ≥ 100 × 10^9/L; d. White blood cell count (WBC) ≥ 3 × 10^9/L;
  • Biochemical tests: a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; b. Total bilirubin (TBIL) ≤ 1.5 × ULN; c. Serum creatinine (Cr) ≤ 1.5 × ULN (or creatinine clearance (CCr) ≥ 60 mL/min);
  • Coagulation function: activated partial thromboplastin time (APTT), International normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
  • Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should also be assessed; if FT3 and FT4 levels are normal, the patient can be enrolled);
  • Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;
  • Female participants must agree to use contraception (e.g., intrauterine device [IUD], contraceptive pills, or condoms) during the study and for 6 months after the study ends; a negative serum pregnancy test must be obtained within 7 days prior to enrollment, and participants must not be breastfeeding. Male participants must also agree to use contraception during the study and for 6 months after the study ends.

Who cannot join

  • Participants with any of the following criteria will be excluded from the study:
  • Presence of other malignant tumors (except for previously cured basal cell carcinoma of the skin).
  • Diagnosis of cervical esophageal cancer.
  • Severe hypersensitivity reactions following the administration of other monoclonal antibodies.
  • Any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilator intervention). However, patients with the following conditions may be included: vitiligo, psoriasis, alopecia that do not require systemic treatment, well-controlled type 1 diabetes, and hypothyroidism with normal thyroid function under replacement therapy.
  • Use of immunosuppressants, systemic, or absorbable local hormone therapy to achieve immunosuppressive effects (doses > 10 mg/day of prednisone or equivalent), and continuing use within 2 weeks of the first dose.
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  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Uncontrollable neurological symptoms from brain metastases, spinal cord compression, or carcinomatous meningitis occurring within 4 weeks prior to the first dose, or evidence of brain or leptomeningeal disease found on CT or MRI screening.
  • Presence of any severe and/or uncontrolled disease, including:
  • Acute or persistent myocardial ischemia or myocardial infarction, poorly controlled clinically significant arrhythmias, and NYHA class II or higher heart failure; LVEF < 50%.
  • Active or uncontrolled severe infections (≥ CTCAE grade 2 infections).
  • Vaccination with preventive or attenuated vaccines within 4 weeks prior to the first dose.
  • Any factors, as judged by the investigator, that could lead to premature termination of the study, such as other serious illnesses (including mental illness) requiring concurrent treatment, significant laboratory abnormalities, or family or social factors that could affect participant safety.
  • For participants who are HBsAg (+) and/or HBcAb (+), HBV DNA must be < 500 IU/mL (if the local center's lower limit of detection is higher than 500 IU/mL, the investigator may decide on enrollment based on specific circumstances) and must continue to receive effective anti-HBV treatment during the study, or must have initiated treatment with entecavir or tenofovir prior to the study drug.
  • For participants who are HCV antibody positive, HCV-RNA testing is required; those with HCV-RNA > 10^3 copies/mL will be excluded.
  • Positive HIV test.

Trial locations and contacts

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

Lijie Tan, Professor contact

+8613681972151

tan.lijie@zs-hospital.sh.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Youhua Jiang, +8613705817867, jiangyh@zjcc.org.cn

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

    Lijie Tan, Professor, +8613681972151, tan.lijie@zs-hospital.sh.cn

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

    Shaobin Chen, +8613417000759, chensb535176@hotmail.com

    Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110041

    Yegang Ma, +8618900918123, mayegang@163.com

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300202

    Peng Tang, +8618622221615, tangpeng1028@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled, Multicenter Clinical Study of Benmelstobart Combined With Radiochemotherapy Versus Radiochemotherapy as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma

This study will explore the efficacy and safety of benmelstobart combined with radiochemotherapy compared to radiochemotherapy alone as neoadjuvant treatment for esophageal squamous cell carcinoma. It will also compare the effectiveness and safety of low-dose radiotherapy versus standard-dose radiotherapy in neoadjuvant regimens that include benmelstobart with concurrent radiochemotherapy. This research may provide more treatment options for patients with esophageal squamous cell carcinoma.

Read the detailed description

Eligible participants will be randomly assigned in a 1:1 ratio to either the benmelstobart plus radiochemotherapy group or the radiochemotherapy group. Surgery will be performed 6-8 weeks after the completion of neoadjuvant treatment, with the primary endpoint being the rate of pathological complete response (pCR).

Being tested
Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy, Paclitaxel + Carboplatin + Radiotherapy
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.

  • Benmelstobart+ Paclitaxel + Carboplatin+ RadiotherapyDrug

    Benmelstobart: 1200 mg, i.v.gtt , d1, 22; Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week(If the number of patients achieving pCR in this group is ≥ 18 with the first 30 patients enrolled, the subsequent 20 patients will receive a reduced dose of 36 Gy in 20 fractions, 5 days per week.)

  • Paclitaxel + Carboplatin + RadiotherapyDrug

    Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week

Study groups in NCT06637163
Study groupRoleWhat they receive
Benmelstobart combined with radiochemotherapyExperimentalBenmelstobart + Paclitaxel + Carboplatin + Radiotherapy
Receives: Drug: Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy
radiochemotherapyActive comparatorPaclitaxel + Carboplatin + Radiotherapy
Receives: Drug: Paclitaxel + Carboplatin + Radiotherapy

What is being measured

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

  1. Pathological complete response (pCR)

    The ratio of patients with no residual cancer cells found in the pathological examination after treatment.

    Measured: 4 months

Secondary outcomes (9)

  1. Major pathologic response (MPR)

    The percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.

    Measured: 4 months

  2. Overall response rate (ORR)

    The proportion of patients achieved a best overall tumor response of complete response (CR) or partial response (PR).

    Measured: 4 months

  3. Diseases control rate (DCR)

    The proportion of patients achieved CR+PR+ stable disease (SD).

    Measured: 4 months

  4. R0 resection rate

    The proportion of subjects who could undergo R0 resection.

    Measured: 4 months

  5. Disease free survival (DFS), 1y-DFS

    The time from surgery to the onset of tumor recurrence or death from any cause.

    Measured: 15 months

  6. Overall survival (OS), 1y-OS

    The time from randomization to the time of death from any cause.

    Measured: 15 months

  7. Surgical-related Indicators

    Surgical Time: Defined as the duration from the start to the end of the surgery for the participant.

    Intraoperative Blood Loss: Defined as the amount of blood lost by the participant during the surgery.

    Postoperative Length of Stay: Defined as the duration from the end of surgery until the participant is discharged.

    Perioperative Complication Rate: Defined as the percentage of participants who experience complications during the perioperative period among all participants.

    Measured: 1 months

  8. Neoadjuvant Treatment Completion Rate

    The percentage of participants who complete neoadjuvant treatment among all participants.

    Measured: 1 months

  9. Adverse events

    The severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard.

    Measured: 15 months

Timeline

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

  1. First posted15 Oct 2024
  2. Study start24 Oct 2024
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2027 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637163
Sponsor's protocol ID
B2024-236R
Status last verified
Oct 2024
First submitted
9 Oct 2024
Last updated
17 Apr 2025
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 Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy and Paclitaxel + Carboplatin + Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 5 sites in China.

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 12 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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 Lijie Tan, Professor (+8613681972151, tan.lijie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) (time frame: 4 months). 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 NCT06637163.

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 17 Apr 2025.

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