Treatment for advanced esophageal squamous cell carcinoma using adebrelimab and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of adebrelimab, an immunotherapy agent, in combination with or without induction chemotherapy for patients with unresectable locally advanced esophageal squamous cell carcinoma. The study is designed as a prospective, two-cohort, multicenter trial where participants are assigned to different treatment regimens based on their CPS scores. Cohort 1 receives adebrelimab alone, while cohort 2 receives adebrelimab along with chemotherapy agents carboplatin/cisplatin and paclitaxel/nab-paclitaxel. Both cohorts will undergo concurrent chemoradiotherapy, with the primary endpoint being the complete clinical response rate.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Yong Yang, MD — Fujian Medical University Union Hospital
• Study coordinator: Yong Yang, Doctor
• Email: dr_yangyong1983@163.com
• Phone: 18813019084

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• Neoadjuvant adebrelimab plus chemotherapy for esophageal squamous cell carcinoma

  This study will test whether giving adebrelimab together with chemotherapy before surgery helps people with locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 2 The Affiliated Hospital of Putian University · Putian, Fujian · NCT07437898

• Adebelizumab with chemotherapy given with radiotherapy at the same time versus after radiotherapy for extensive-stage small cell lung cancer

  This study tests whether adding adebelizumab to chemo and radiotherapy works better when given at the same time as radiotherapy compared to after radiotherapy in adults with extensive-stage SCLC.

  Recruiting Phase 2 Peking University Cancer Hospital & Institute · Beijing, Beijing Municipality · NCT06768307

• Combining stereotactic radiotherapy with immunotherapy and chemotherapy for treating triple-negative breast cancer

  This study is testing if combining a new treatment with radiation and chemotherapy can help women with triple-negative breast cancer do better than just chemotherapy alone.

  Recruiting Phase 2 Shengjing Hospital · Shenyang, Liaoning · NCT06165900

• MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC

  This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07894458

• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

  This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886047

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.