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

NCT06510660 | Recruiting Phase 2

• 1 other identifier: RICE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Squamous Cell Carcinoma; Immunotherapy; Biomarkers

Outcome Measures

Primary Outcomes (1)

• cCR

  Clinical complete response rates.

  Up to 6 months.

Secondary Outcomes (7)

• OS

  From date of enrollment until the date of death from any cause, assessed up to 5 years.

• PFS

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.

• ORR

  Up to 6 months.

• DoR

  Up to 3 years.

• DCR

  Up to 6 months.

Other Outcomes (1)

• Biomarker analysis

  Up to 6 months.

Study Arms (2)

Adebrelimab+Sequential Concurrent Chemoradiotherapy

EXPERIMENTAL

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.

Drug: adebrelimab

Adebrelimab+Chemotherapy+Sequential Concurrent Chemoradiotherapy

EXPERIMENTAL

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.

Drug: adebrelimab

Interventions

adebrelimab 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; Adebrelimab+Sequential Concurrent Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years, male or female;
• Have not received systemic or localized treatment in the past;
• 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;
• ECOG score of 0-1;
• Life expectancy ≥ 3 months;
• Adequate organ function;
• 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；
• Subjects will voluntarily enroll in the study, sign an informed consent form, be compliant, and cooperate with follow-up visits.

You may not qualify if:

• Subjects with low body weight (BMI \<18.5kg/m2) or ≥10% weight loss in the 2 months prior to screening;
• 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;
• Prior treatment with immunotherapy;
• Treatment with any other clinical investigational drug or participation in another interventional clinical study within 4 weeks prior to first use of study drug;
• Planning to receive or have received a prophylactic or live attenuated vaccine within 4 weeks prior to the first dose of study drug;
• Receiving corticosteroid hormone therapy within 2 weeks prior to first use of study drug;
• Subjects who have received a previous tissue/organ transplant or allogeneic hematopoietic stem cell transplant;
• Active, known or suspected autoimmune disease;
• Uncontrolled cardiac clinical symptoms or disease;
• Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
• Subjects with active tuberculosis or a history of active tuberculosis infection within 12 months prior to screening, with or without treatment;
• History of interstitial lung disease (except radiation pneumonitis not treated with hormonal therapy), or history of non-infectious pneumonia;
• Active hepatitis B virus or hepatitis C virus infection. Positive HIV test or known acquired immunodeficiency syndrome (AIDS);
• 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);
• Known hypersensitivity to any of the investigational drugs or excipients;

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yong Yang, Doctor

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

• Lei Zhao

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yang, Doctor

CONTACT

18813019084; dr_yangyong1983@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: July 19, 2024
• Study Start: April 11, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)