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Trial Title:
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
NCT ID:
NCT06510660
Condition:
Esophageal Squamous Cell Carcinoma
Immunotherapy
Biomarkers
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
adebrelimab
Description:
The study was divided into two cohorts based on CPS score, with those with CPS scores ≥10
receiving induction therapy with adebrelimab alone and those with CPS scores <10
receiving induction therapy with adebrelimab in combination with chemotherapy. At the end
of the induction period, concurrent radiotherapy treatment was administered
Arm group label:
Adebrelimab+Chemotherapy+Sequential Concurrent Chemoradiotherapy
Arm group label:
Adebrelimab+Sequential Concurrent Chemoradiotherapy
Summary:
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy
followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal
squamous cell carcinoma
Detailed description:
This is a prospective, two-cohort, multicenter clinical study. Subjects received
different treatments based on their CPS scores. During induction therapy, subjects in
cohort 1 (CPS score ≥10) received adebrelimab, while cohort 2 (CPS score < 10) were
administered adebrelizumab + carboplatin/cisplatin + paclitaxel/nab-paclitaxel. Both
groups received carboplatin/cisplatin + paclitaxel/nab-paclitaxel combined radiotherapy
during concurrent chemoradiotherapy. The primary endpoint was cCR rate.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18-70 years, male or female;
2. Have not received systemic or localized treatment in the past;
3. Histologically or cytologically confirmed esophageal squamous cell carcinoma (AJCC
8th edition clinical stage II-IVA). IVB stage thoracic esophageal cancer with
supraclavicular lymph node metastasis only. No surgical resection or refusal of
surgical resection;
4. ECOG score of 0-1;
5. Life expectancy ≥ 3 months;
6. Adequate organ function;
7. Fertile men and women must agree to use contraception during the study period and
for six months after the last drug used in the study；
8. Subjects will voluntarily enroll in the study, sign an informed consent form, be
compliant, and cooperate with follow-up visits.
Exclusion Criteria:
1. Subjects with low body weight (BMI <18.5kg/m2) or ≥10% weight loss in the 2 months
prior to screening;
2. Esophageal lesions with significant invasion of neighboring organs (e.g., aorta,
trachea), or deep and large ulcers with a high risk of bleeding or fistula
formation, or previous esophageal perforation or fistula within 6 months prior to
screening;
3. Prior treatment with immunotherapy;
4. Treatment with any other clinical investigational drug or participation in another
interventional clinical study within 4 weeks prior to first use of study drug;
5. Planning to receive or have received a prophylactic or live attenuated vaccine
within 4 weeks prior to the first dose of study drug;
6. Receiving corticosteroid hormone therapy within 2 weeks prior to first use of study
drug;
7. Subjects who have received a previous tissue/organ transplant or allogeneic
hematopoietic stem cell transplant;
8. Active, known or suspected autoimmune disease;
9. Uncontrolled cardiac clinical symptoms or disease;
10. Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
11. Subjects with active tuberculosis or a history of active tuberculosis infection
within 12 months prior to screening, with or without treatment;
12. History of interstitial lung disease (except radiation pneumonitis not treated with
hormonal therapy), or history of non-infectious pneumonia;
13. Active hepatitis B virus or hepatitis C virus infection. Positive HIV test or known
acquired immunodeficiency syndrome (AIDS);
14. Prior history of other malignancies within 5 years (except non-melanoma skin cancer,
limited prostate cancer, or any early stage tumor treated by radical resection);
15. Known hypersensitivity to any of the investigational drugs or excipients;
16. The presence of other serious physical or mental illnesses or abnormal laboratory
tests that may increase the risk of participation in the study or interfere with the
results of the study, and subjects who, in the opinion of the investigator, are
unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Yang, Doctor
Phone:
18813019084
Email:
dr_yangyong1983@163.com
Start date:
April 11, 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06510660
