A Study of Adebrelimab Combined With Chemoradiotherapy in the Treatment of Esophageal Small Cell Carcinoma

NCT06478264 | Not Yet Recruiting Phase 2

• 1 other identifier: ADVENT-ESCC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of esophageal small cell carcinoma

Conditions

Esophageal Small Cell Carcinoma

Keywords

Esophageal Small Cell Carcinoma; Adebrelimab; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.

  1 year

Secondary Outcomes (6)

• Disease control rate (DCR)

  1 year

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  2 years

• One-Year Overall Survival Rate

  1 year

• Two-Years Overall Survival Rate

  2 years

Other Outcomes (2)

• Explore potential biomarkers in tumor tissue

  1 year

• Explore potential biomarkers in the Peripheral Blood of Cancer Patients

  1 year

Study Arms (1)

Single arm

EXPERIMENTAL

EP regimen:Etoposide and Cisplatin or Carboplatin Cohort A: Stage I-IVa , EP combined with adebrelimab induction therapy for 2 cycles, sequential thoracic radiotherapy combined with EP chemotherapy for 2 cycles, and adebrelimab immunomaintenance therapy until PD or over 1 year.Thoracic radiotherapy regimen : prescription dose: PTV 50Gy/25f. Cohort B: Stage IVb , EP regimen combined with adebrelimab injection immunotherapy for 4 cycles, PR or SD patients evaluated for 3 months, followed by chest radiotherapy, and adebrelimab immunization continued until PD or full 1 year.Chest radiotherapy : prescribed dose: PTV 30Gy/10f.

Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin; Drug: Adebrelimab; Radiation: radiotherapy

Interventions

Etoposide DRUG

100mg/m\^2, intravenous infusion for 1-3 days,21 days/cycle, 4 cycles

Single arm

Cisplatin DRUG

25mg/m\^2 ,intravenous infusion for 1-3 days ,21 days/cycle, 4 cycles

Single arm

Carboplatin DRUG

Carboplatin (AUC = 5) on 1 Day,21 days/cycle, 4 cycles ;

Single arm

Adebrelimab DRUG

1200mg adebrelimab was given intravenously on 2 day after chemotherapy,21 days/cycle, continuous use.

Also known as: SHR-1316

Single arm

radiotherapy RADIATION

Stage I-IVa , prescription dose: PTV 50Gy/25f. Stage IVb ,prescribed dose: PTV 30Gy/10f.

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Sign a written informed consent to join the study voluntarily;
• \. Histologically or cytologically confirmed patients with small cell carcinoma of the esophagus staging T1N0M0 but unable to tolerate surgery or refusing surgery and patients staging T2-4N0-3M0 \[according to AJCC 8th edition TNM criteria\];
• \. Age 18-75 years old, male or female;
• \. ECOG PS 0-1;
• \. No previous systemic treatment for esophageal small cell carcinoma;
• \. At least one measurable lesion (according to RECIST1.1 criteria);
• \. Normal functioning of major organs, including:
• Blood routine examination (no blood component, cell growth factor, white enhancer, platelet enhancer, anemia correction drugs are allowed within 14 days before the first use of the study drug) :
• White blood cell count ≥4.0×10\^9/L
• Neutrophil count ≥1.5×10\^9/L
• Platelet count ≥80×10\^9/L
• Hemoglobin ≥90 g/L
• Blood biochemical examination:
• Total bilirubin ≤1.5×ULN
• ALT≤2.5 x ULN, AST≤2.5 x ULN,

You may not qualify if:

• \. Esophageal perforation or hematemesis;
• \. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• \. Uncontrolled hypercalcemia or symptomatic hypercalcemia;
• \. Previously received immune checkpoint blocking therapy;
• \. Subjects who required systemic corticosteroids (\> 10 mg/ day effective dose of prednisone) or other immunosuppressive agents within 14 days prior to initial dosing or during the study period. However, in the absence of active autoimmune disease, subjects were allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at a dose ≤10 mg/ day of prednisone effectiveness.
• \. There are clinical symptoms or diseases of heart that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias that are not well controlled without or after clinical intervention;
• \. Poor nutritional status, BMI \< 18.5 Kg/m\^2; If it is corrected before enrollment after symptomatic nutritional support, it can continue to be considered for enrollment after evaluation by the principal investigator;
• \. Adverse events greater than grade 2 caused by treatment received before the first use of the investigatory drug that have not recovered (i.e., become grade 1 or reach baseline level), and adverse events (such as neurotoxicity) that are difficult to recover quickly as determined by the investigator can be included;
• \. History of allergy to any component of adbelimab, etoposide, cisplatin or carboplatin;
• \. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
• \. Severe infections (CTCAE \> Grade 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use;
• \. Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of active pulmonary tuberculosis infection more than 1 year ago without formal treatment;
• \. Hereditary bleeding tendency or blood clotting dysfunction. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months prior to enrollment, such as hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline;
• \. Active hepatitis B (HBV DNA≥2000 IU/mL or 10\^4 copies/mL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the lower limit of assay);
• \. Pregnant or lactating women;

Sponsors & Collaborators

• Zhangzhou Municipal Hospital: lead

Related Publications (1)

• Wen J, Fang S, Hu Y, Xi M, Weng Z, Pan C, Luo K, Ling Y, Lai R, Xie X, Lin X, Lin T, Chen J, Liu Q, Fu J, Yang H. Impacts of neoadjuvant chemoradiotherapy on the immune landscape of esophageal squamous cell carcinoma. EBioMedicine. 2022 Dec;86:104371. doi: 10.1016/j.ebiom.2022.104371. Epub 2022 Nov 23.

  PMID: 36434949 RESULT

MeSH Terms

Interventions

Etoposide; Cisplatin; Carboplatin; Radiotherapy

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Therapeutics

Study Officials

• Weilin Chen

  Zhangzhou Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Yiming Li

  First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Chong Deng

  First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Shouguo Li

  Zhongshan Hospital Affiliated to Xiamen University

  PRINCIPAL INVESTIGATOR

• Yuyi Lin

  Xiamen Second Hospital

  PRINCIPAL INVESTIGATOR

• Qunrong Cai

  The Second Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Wenjie Cai

  Quanzhou First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weilin Chen

CONTACT

13709385466; cwlqiao@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of radiation oncology

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: July 13, 2024
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2027
• Last Updated: June 27, 2024

Record last verified: 2024-06