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NCT Number: NCT06037655

Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC

The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Age ≥ 18 years,≤ 75 years
  • Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
  • Ability to provide written informed consent prior to participation in any study-related procedure
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
  • Adequate organ function

Exclusion criteria

  • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
  • Known history of a serious allergy to any monoclonal antibody
  • Any active malignancy prior to the start of treatment
  • Active or history of autoimmune disease
  • Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
  • Pregnant or lactating women

Treatment and study plan

Total Neoadjuvant Treatment

Drug

Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 18 weeks

    ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1

Secondary outcomes

  1. overall survival (OS)

    Time frame: 2 years

    Overall survival

Other outcomes

  1. Progression free survival (PFS)

    Time frame: 2 years

    PFS is defined as time interval from recruitment to tumor progression or censoring

  2. Pathological Complete Response Rate (pCR)

    Time frame: 18 weeks

    pathological complete response rate

  3. Major Pathological Response Rate (MPR)

    Time frame: 18 weeks

    MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangcheng Li

CONTACT

[email protected]

18951999088

Xiaofeng Chen

CONTACT

13585172066

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study

Acronym: Modified

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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