Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJin Xu

About this trial

This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign informed consent;

Aged 18-75 years (inclusive);

Histologically or cytologically confirmed pancreatic cancer;

Unresectable locally advanced or metastatic pancreatic cancer, as determined by the investigator;

Disqualifiers

The subject has any known active autoimmune disease;

Subjects have any complications requiring systemic treatment with corticosteroids such as prednisone (> 10mg/ day) or have used immunosuppressive drugs within 14 days prior to initial administration;

Subjects received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to initial administration;

Subjects are participating in another clinical trial or have received a drug intervention from another clinical trial within 4 weeks prior to the first dose;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab: 1200mg,iv,d1,q3w;

  • AG

    Drug

    Gemcitabine: 1000 mg/m² ,iv,d1、d8,q3w; Nab-paclitaxel: 125 mg/m² ,iv,d1、d8,q3w;

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective response rate

Time frame
up to 20 weeks

Secondary outcomes

1

PFS

Progression-free survival

Time frame
up to 20 weeks
2

OS

Overall survival

Time frame
1 year
3

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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Jin Xu

Lead sponsor

Fudan University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: