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Biliary Tract CancerPhase 2NCT04571710

A Trial of SHR1258 in Patients With Biliary Tract Cancer

A Phase 2 study testing SHR1258 in people with Biliary Tract Cancer, run by Jiangsu HengRui Medicine Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study is being conducted to evaluate the efficacy and safety of SHR1258 in subjects with advanced/ metastatic HER2-altered biliary tract cancers Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
SHR1258
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Nov 2020to 5 Jun 2025
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

  • enrollment into the study:
  • Signed and dated written informed consent which is approved by Institutional Review Board (IRB)/Ethics Committee (EC), willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures.
  • Male or female, ≥18 years old.
  • Histologically or cytologically confirmed (at a local laboratory) BTC
  • Received up to two prior regimen of systemic therapy for advanced disease, including 1 gemcitabine-containing regimen, and experienced disease progression after or developed intolerance to the most recent prior therapy.
  • Sufficient tumor tissue samples (archival or fresh biopsy samples) will be provided by all subjects prior to the administration of pyrotinib (for retrospective confirmation of HER2 alteration through a central laboratory if applicable).
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  • Must have measureable disease per RECIST v1.1. The definition of CT or MRI measurable lesion as the target lesion: according to RECIST v1.1, the long diameter of such lesion should be ≥ 10 mm by the CT scan or the short diameter of enlarged lymph nodes ≥ 15 mm.
  • The laboratory test values must meet the functional level of important organs/systems meets
  • ECOG-PS (see Appendix 2): 0 - 1.
  • If subjects have active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be < 500 IU/mL and are willing to receive antiviral therapy throughout the study; subjects with positive hepatitis C (HCV) ribonucleic acid (RNA) must receive antiviral therapy in accordance with the local standard treatment guideline and have ≤ CTCAE Grade 1 elevated hepatic function.
  • Women of childbearing potential (WOCBP) must have a serum pregnancy test within 7 days before the first dose and the result is negative. WOCBP and male subjects whose partners are WOCBP must agree to use effective contraception method during the study period and within 8 weeks after the last dose of study medication.
  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • Signed and dated written informed consent which is approved by Institutional Review Board (IRB)/Ethics Committee (EC), willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures.
  • Male or female, ≥18 years old.
  • Histologically or cytologically confirmed (at a local laboratory) BTC
  • Received up to two prior regimen of systemic therapy for advanced disease, including 1 gemcitabine-containing regimen, and experienced disease progression after or developed intolerance to the most recent prior therapy.
  • Sufficient tumor tissue samples (archival or fresh biopsy samples) will be provided by all subjects prior to the administration of pyrotinib (for retrospective confirmation of HER2 alteration through a central laboratory if applicable).
  • Must have measureable disease per RECIST v1.1. The definition of CT or MRI measurable lesion as the target lesion: according to RECIST v1.1, the long diameter of such lesion should be ≥ 10 mm by the CT scan or the short diameter of enlarged lymph nodes ≥ 15 mm.
  • The laboratory test values must meet the functional level of important organs/systems meets
  • ECOG-PS (see Appendix 2): 0 - 1.
  • If subjects have active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be < 500 IU/mL and are willing to receive antiviral therapy throughout the study; subjects with positive hepatitis C (HCV) ribonucleic acid (RNA) must receive antiviral therapy in accordance with the local standard treatment guideline and have ≤ CTCAE Grade 1 elevated hepatic function.
  • Women of childbearing potential (WOCBP) must have a serum pregnancy test within 7 days before the first dose and the result is negative. WOCBP and male subjects whose partners are WOCBP must agree to use effective contraception method during the study period and within 8 weeks after the last dose of study medication.

Who cannot join

  • Subjects presenting with any of the following will not be enrolled into the study:
  • Prior receipt of HER2-targeted therapy.
  • Concurrent anticancer therapy, other than the therapies being tested in this study.
  • Radiation therapy administered within 2 weeks of first dose of study treatment.
  • Laboratory values at screening outside the protocol-defined range.
  • Clinically significant or uncontrolled cardiac disease.
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  • Target disease exclusion criteria:
  • 1) Malignant tumors with other pathological types, such as mixed cancer, double primary cancers.
  • 2) Medical history of other active malignancies within last 5 years. 3) Subjects with active central nervous system (CNS) metastases are excluded. Subjects with history or evidence of current leptomeningeal metastases are excluded.
  • 4) By the date of first dose of study treatment, the washout period of previous drug treatment / medical intervention does not meet the following requirements 7. Medical history exclusion criteria:
  • Severe cardiac disease
  • Prior to the first dose of study treatment, patients with the following conditions: inability to swallow, chronic diarrhea, intestinal obstruction, gastrointestinal perforation or gastrectomy, colitis or other diseases or special conditions that affect drug administration and absorption.
  • Prior to the first dose of study treatment, patients with severe effusions with clinical symptoms
  • Symptoms of severe infection or evidence for microbiological/viral diagnosis.
  • Congenital or acquired immunodeficiency (e.g., human immunodeficiency virus [HIV] infection).
  • 8. History of allergy to the study drugs or components. 9. Pregnancy or breastfeeding. 10. Concomitant treatments exclusion criteria:
  • Within 2 weeks prior to the first dose of study treatment, or during the study period, patients receive or are anticipated to receive continuous strong CYP3A4 inducers or inhibitors, P-gp inhibitors.
  • 11. Others:
  • Per investigator's judgment, other diseases or laboratory evidence that would cause serious threats to the safety of the patients, or which are not in the best interest of the patient to participate in the study are excluded
  • Per investigator's judgment, other situations that may confuse the study results or would affect the subjects' ability to comply with study procedures are excluded, such as alcoholism, drug abuse, criminal detention, etc.

About this study

Official title: A Phase 2 Study of Pyrotinib in Patients With Advanced/ Metastatic HER2-Altered Biliary Tract Cancers Who Have Failed One or Two Prior Lines of Therapies

The study is being conducted to evaluate the efficacy and safety of SHR1258 in subjects with advanced/ metastatic HER2-altered biliary tract cancers

Being tested
SHR1258
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • SHR1258Drug

    Drug: SHR1258 400mg

Study groups in NCT04571710
Study groupRoleWhat they receive
Treatment groupExperimentalIntervention: Drug: SHR1258 400mg
Receives: Drug: SHR1258

What is being measured

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

  1. Objective response rate

    Objective response rate (ORR) evaluated by Blinded Independent Radiology Review Committee (BIRC) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Measured: up to 2 years

Secondary outcomes (6)

  1. DOR

    Duration of response

    Measured: up to 2 years

  2. DCR

    Disease Control Rate

    Measured: up to 2 years

  3. PFS

    Progression-Free-Survival

    Measured: up to 2 years

  4. OS

    overall survival

    Measured: up to 2 years

  5. AEs+SAEs

    Adverse event

    Measured: from the first drug administration to within 28 days for the last SHR1258 dose

  6. Cmax

    Peak Plasma Concentration

    Measured: up to 2 years

Timeline

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

  1. First posted1 Oct 2020
  2. Study start1 Nov 2020 (estimated)
  3. Primary completion5 Jun 2025
  4. Study completion5 Jun 2025

Why it stopped: The sponsor's R\&D strategy is adjusted.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571710
Sponsor's protocol ID
HR-BLTN-II-BTC
Status last verified
Jul 2025
First submitted
17 Sep 2020
Last updated
24 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR1258 in people with Biliary Tract Cancer, run by Jiangsu HengRui Medicine Co., Ltd..

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 22 inclusion and 20 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: withdrawn, as of the sponsor's last update on 24 Jul 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: up to 2 years). 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 NCT04571710.

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 24 Jul 2025.

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