Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC

NCT ID: NCT06510660

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma; Immunotherapy; Biomarkers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adebrelimab+Sequential Concurrent Chemoradiotherapy

Participants with CPS score ≥10 were enrolled.

Induction therapy: adebrelimab 1200mg iv d1 q3w x 2 cycles for 6 weeks.

Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks.

Group Type: EXPERIMENTAL

adebrelimab

Intervention Type: DRUG

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

Adebrelimab+Chemotherapy+Sequential Concurrent Chemoradiotherapy

Participants with CPS score <10 were enrolled.

Induction therapy: adebrelimab 1200mg iv d1 q3w + carboplatin AUC=6 / cisplatin 75mg/m2 d1 q3w + paclitaxel 175mg/m2 / nab-paclitaxel 260mg/m2 d1 q3w × 2 cycles for 6 weeks.

Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks.

Group Type: EXPERIMENTAL

adebrelimab

Intervention Type: DRUG

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

Interventions

adebrelimab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong Yang

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Yang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Lei Zhao

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yong Yang, Doctor

Role: CONTACT

dr_yangyong1983@163.com

18813019084

Facility Contacts

Yong Yang, Doctor

Role: primary

dr_yangyong1983@163.com

18813019084

Other Identifiers

RICE

Identifier Type: -

Identifier Source: org_study_id