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Esophageal Squamous Cell CarcinomaPhase 2NCT05265962

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

A Phase 2 study testing Decitabine plus Penpulimab in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Decitabine plus Penpulimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
No sites listed yet
Study dates
1 Dec 2022to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 .
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  • 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).

Trial locations and contacts

No sites are listed yet.

Feng Wang, Doctor contact

13938244776

fengw010@163.com

About this study

Official title: An Single-arm Open-label Phase II Study of Decitabine Plus Penpulimab as Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma Treated With PD-1 Blockade

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

Read the detailed description

Although immune checkpoint inhibitors (ICIs) have been tested in esophageal squamous cell carcinoma(ESCC) with demonstrated clinical efficacy，a significant number of patients have an initial response will develop a secondary resistance and relapse. recent studies on the role of epigenetics in immune evasion have exposed a key role for epigenetic modulators in augmenting the tumour microenvironment and restoring immune recognition and immunogenicity. These discoveries have established a highly promising basis for studies using combined epigenetic and immunotherapeutic agents as anti-cancer therapies. Decitabine is a novel orally active benzamide-type histone deacetylase inhibitor that has shown in vitro activities against a wide array of neoplasms. Hence, the study of decitabine plus penpulimab(AK-105) as second-line therapy for advanced ESCC treated with PD-1 blockade was performed.

Being tested
Decitabine plus Penpulimab
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decitabine plus PenpulimabDrug

    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.

Study groups in NCT05265962
Study groupRoleWhat they receive
Decitabine plus PenpulimabExperimentalPts 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.
Receives: Drug: Decitabine plus Penpulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

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

    Measured: up to 24 months

Secondary outcomes (5)

  1. ORR

    Defined as the proportion of patients with a documented complete response, partial response(CR+PR)

    Measured: up to 24 months

  2. PFS

    From date of initial treatment until the date of first documented progression or date of death from any cause

    Measured: Up to 24 months

  3. DOR

    Refers to the time when the tumor is first evaluated as CR or PR until the first assessment is PD (Progressive Disease) or any cause of death.

    Measured: up to 24 months

  4. DCR

    Defined as the proportion of patients with a documented complete response, partial response and stable response(CR+PR+SD)

    Measured: up to 24 months

  5. Adverse Events (Safety)

    Adverse Events

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265962
Sponsor's protocol ID
WF-ESCC
Status last verified
Feb 2022
First submitted
7 Feb 2022
Last updated
4 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Decitabine plus Penpulimab in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Feng Wang, Doctor (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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