Trial Title:
Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC
NCT ID:
NCT06637163
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy
Description:
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.)
Arm group label:
Benmelstobart combined with radiochemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel + Carboplatin + Radiotherapy
Description:
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
Arm group label:
radiochemotherapy
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. 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.
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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):
1. 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;
2. 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);
3. Coagulation function: activated partial thromboplastin time (APTT),
International normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;
4. 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);
5. 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.
Exclusion Criteria:
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.
- 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:
1. Acute or persistent myocardial ischemia or myocardial infarction, poorly
controlled clinically significant arrhythmias, and NYHA class II or higher
heart failure; LVEF < 50%.
2. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of Shantou University Medical College
Address:
City:
Shantou
Zip:
515041
Country:
China
Contact:
Last name:
Shaobin Chen
Phone:
+8613417000759
Email:
chensb535176@hotmail.com
Facility:
Name:
Liaoning Cancer Hospital and Institute
Address:
City:
Shenyang
Zip:
110041
Country:
China
Contact:
Last name:
Yegang Ma
Phone:
+8618900918123
Email:
mayegang@163.com
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Lijie Tan, Professor
Phone:
+8613681972151
Email:
tan.lijie@zs-hospital.sh.cn
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300202
Country:
China
Contact:
Last name:
Peng Tang
Phone:
+8618622221615
Email:
tangpeng1028@126.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Youhua Jiang
Phone:
+8613705817867
Email:
jiangyh@zjcc.org.cn
Start date:
October 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637163
