Actively Recruiting
Adebrelimab with or Without Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Phase 2 Trial
Led by Fujian Medical University Union Hospital · Updated on 2024-09-19
48
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fujian Medical University Union Hospital
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well adebrelimab, with or without induction chemotherapy, works when followed by concurrent chemoradiotherapy for people with unresectable locally advanced esophageal squamous cell carcinoma. This phase 2 trial divides participants into two groups based on their CPS scores to better understand treatment effects and safety. Participants with a CPS score of 10 or higher receive induction therapy with adebrelimab alone, given intravenously every three weeks for two cycles over six weeks. Those with CPS scores below 10 receive adebrelimab combined with chemotherapy drugs carboplatin or cisplatin and paclitaxel or nab-paclitaxel, also over two cycles in six weeks. Both groups then receive concurrent chemoradiotherapy including carboplatin or cisplatin and paclitaxel or nab-paclitaxel weekly for five weeks alongside 50Gy radiotherapy delivered in 25 fractions. During the study, participants undergo assessments to measure complete clinical response up to six months after treatment starts. Researchers also track overall survival, progression-free survival, response rates, duration of response, disease control rate, radiotherapy completion, and adverse events over various time frames up to five years. The study involves regular monitoring and follow-up visits to evaluate treatment effects and safety in adults aged 18 to 70 years with this form of esophageal cancer.
CONDITIONS
Brief Title
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, male or female
- No prior systemic or localized treatment for esophageal squamous cell carcinoma
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, clinical stage II to IVA or stage IVB with supraclavicular lymph node metastasis only
- No surgical resection planned or patient refuses surgical resection
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function
- Fertile men and women agree to use contraception during the study and for six months after last study drug
- Voluntary enrollment with signed informed consent and willingness to comply with follow-up visits
You will not qualify if you...
- Low body weight (BMI below 18.5 kg/m2) or 10% or more weight loss within 2 months before screening
- Esophageal lesions with significant invasion into nearby organs or high risk of bleeding or fistula
- Previous esophageal perforation or fistula within 6 months before screening
- Prior immunotherapy treatment
- Participation in another clinical trial or use of other investigational drugs within 4 weeks before study drug
- Planned or recent prophylactic or live attenuated vaccine within 4 weeks before study drug
- Corticosteroid hormone treatment within 2 weeks before study drug
- Previous tissue/organ transplant or allogeneic hematopoietic stem cell transplant
- Active or suspected autoimmune disease
- Uncontrolled heart symptoms or disease
- Active or uncontrolled serious infection (grade 2 or higher)
- Active tuberculosis or history of tuberculosis within 12 months
- History of interstitial lung disease or non-infectious pneumonia
- Active hepatitis B or C, positive HIV test, or known AIDS
- Other malignancies within 5 years, except certain early stage cancers
- Known allergy to study drugs or ingredients
- Serious physical or mental illness or lab abnormalities that increase study risk or interfere with results, or deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive induction therapy based on their CPS score. Those with CPS scores ≥10 receive adebrelimab alone, while those with CPS scores <10 receive adebrelimab combined with chemotherapy.
2 treatment cycles given every 3 weeks
Duration - 5 weeks
Participants receive concurrent chemoradiotherapy consisting of weekly chemotherapy and radiotherapy over 5 weeks.
Weekly visits for treatment and radiotherapy
Duration - Up to 6 months
Participants are monitored for treatment response and safety for up to 6 months after completion of therapy.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
Y
Yong Yang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here