Decitabine Plus Penpulimab as Second-line Therapy for Advanced ESCC Treated With PD-1 Blockade

NCT05265962 | Unknown Phase 2

• 1 other identifier: WF-ESCC
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Decitabine plus Penpulimab as second-line therapy for advanced esophageal squamous cell carcinoma treated with PD-1 blockade

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  From date of initial treatment until the date of death from any cause

  up to 24 months

Secondary Outcomes (5)

• ORR

  up to 24 months

• PFS

  Up to 24 months

• DOR

  up to 24 months

• DCR

  up to 24 months

• Adverse Events (Safety)

  up to 24 months

Other Outcomes (2)

• Tumor mutation burden (TMB)

  up to 24 months

• PD-L1 CPS

  up to 24 months

Study Arms (1)

Decitabine plus Penpulimab

EXPERIMENTAL

Pts received decitabine 10mg/d IV daily x5 every 3 weeks and penpulimab(AK-105) 200 mg intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.

Drug: Decitabine plus Penpulimab

Interventions

Decitabine plus Penpulimab DRUG

Pts received decitabine 10mg/d IV daily x5 every 3 weeks and penpulimab(AK-105) 200 mg intravenously every 3 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.

Decitabine plus Penpulimab

Eligibility Criteria

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

You may qualify if:

• Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
• Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
• Histologically confirmed diagnosis of ESCC.
• Have PD after first-line of PD-1 blockade treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
• Measurable disease per RECIST v1.1 assessed by the local investigator
• ECOG PS 0 or 1
• Newly obtained (preferred) or archival tissue sample available
• Negative urine or serum pregnancy test within 72 h before randomization (females)
• Willing to use an adequate method of contraception throughout the study and for 120 days after the last dose of study medication and up to 180 days after the last dose of cisplatin
• Adequate haematologic function, defined as ANC ≥ 1500/μl, platelet count ≥ 100,000/μl and haemoglobin ≥ 9.0 g/dl or ≥5.6 mmol/l
• Adequate renal function, defined as creatinine ≤ 1.5 × ULN or measured or calculated creatinine clearance ≥ 60 mL/min for those with creatinine levels 1.5 × ULN
• Adequate hepatic function, defined as total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN, and ALT/AST levels ≤ 2.5 × ULN
• Adequate coagulation function, defined as INR ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case PT or aPTT should be within the therapeutic range
• Written informed consent

You may not qualify if:

• Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
• Evidence of complete esophageal obstruction not amenable to treatment.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse
• Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
• Uncontrolled diabetes or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before initial treatment .
• Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
• History of interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, etc.
• Infection (including tuberculosis infection, etc) that requires systemic antibacterial, antifungal or antiviral therapy within 14 days beforeinitial treatment
• A history of severe hypersensitivity reactions to chidamide and monoclonal antibodies.
• Patients with toxicities (as a result of prior anticancer therapy) that have not recovered to ≤Grade 2 or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Decitabine; penpulimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Feng Wang, Doctor

CONTACT

13938244776; fengw010@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: Chief Physician

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 4, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 4, 2022

Record last verified: 2022-02