NCT06420908WithdrawnNot Applicable
Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC): A Prospective, Single-arm, Phase II Clinical Study
Hebei Medical University Fourth Hospital0 sites30 target enrollmentStarted: May 30, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Progression free survival (PFS)
Study Overview
Brief Summary
This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.Age 18-75 years old, both men and women; 2.Histopathology confirmed as esophageal squamous cell carcinoma，stage II-IVa：T1N2-3M0，T2-4bN+M0； 3.If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 4.Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 5.Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 6.According to RECIST 1.1, at least one measurable lesion; 7.ECOG: 0~1; 8.Expected survival period ≥ 12 weeks; 9.Major organ function has to meet the following certeria:
- •Blood routine examination:
- •ANC ≥ 1.5 × 109 / L;
- •PLT ≥ 100 × 109 / L;
- •Biochemical examination:
- •ALT and AST < 2.5×ULN;
- •TBIL ≤ 1.5×ULN;
- •Cr ≤ 1.5×ULN;
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period;
- •Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria
- •Previous history of esophageal cancer surgery；
- •Higher risk of esophageal perforation or fistula；
- •Received systemic immunosuppressive therapy within 14 days prior to the first study medication；
- •Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function;
- •The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- •Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 copies/ml or 500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)；
- •Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur;
- •History of cardiovascular disease with significant clinical significance, including but not limited to: (1) congestive heart failure (NYHA grade>2); (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 3 months; (4) Any supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention;
- •Severe infections within 4 weeks before study drug administration, or active infection with CTCAE ≥ 2 grade treated with antibiotics within 2 weeks before study drug administration;
- •History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •The researchers think inappropriate.
Arms & Interventions
PET-CT responders
Experimental
SUV (PETr) reduction >35%
Intervention: Adebrelimab+TP/FP+ radiation therapy (Drug)
PET-CT non-responders
Experimental
SUV (PETr) reduction ≤35%
Intervention: Adebrelimab+FP/TP+ radiation therapy (Drug)
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
Secondary Outcomes
- 1. Objective response rate (ORR)(tumor assessment every 6 weeks since the treatment began，up to 24 monthss)
- 2. Duration of Overall Response（DoR）(tumor assessment every 6 weeks since the treatment began，up to 24 months)
- 3. Overall survival (OS)(the first day of treatment to death or last survival confirm date,up to 24 months)
- 4. Adverse events(up to 24 months)
Investigators
Jun wang
Principal Investigator
Hebei Medical University Fourth Hospital
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