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NCT06620848RecruitingPhase 2

A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.

A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.

Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
49 (estimated)
First submitted
26 Sept 2024
Start date
21 Nov 2024
Primary completion date
31 Dec 2026
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT06620848

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 49
  • From 21 Nov 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.

Other illness

  • Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.

Other

  • Patients with untreated or active central nervous system tumor metastasis.
  • Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Who the study is looking for

  • 18-75 years old, male or female.
  • Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
  • Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
  • Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • ECOG performance status of 0-1.
  • With a life expectancy of ≥3 months.
  • Have adequate laboratory parameters and organ functions during the screening period.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Zhongshan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.