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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
ClinicalTrials.gov ID: NCT06510660
What this study is testing
What is adebrelimab?
adebrelimab is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- ECOG score of 0-1;
- Life expectancy ≥ 3 months;
You likely can't join if
- people 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...
- Prior treatment with immunotherapy;
- Treatment with any other clinical investigational drug or participation in another treatment clinical study within 4 weeks prior to first use of...
- 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;
See the full eligibility criteria
- 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...
- 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；
- people will voluntarily enroll in the study, sign an informed consent form, be compliant, and cooperate with follow-up visits.
- people 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...
- Prior treatment with immunotherapy;
- Treatment with any other clinical investigational drug or participation in another treatment 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;
- people 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);
- people 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;
- 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 people who, in the opinion...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.