Advanced Biliary Tract CancerPhase 2NCT05009953

Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

A Phase 2 study testing Irinotecan Liposome Injection, SG001 and Fluorouracil in people with Advanced Biliary Tract Cancer and Intrahepatic Cholangiocarcinoma, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma
What is being tested?: Irinotecan Liposome Injection, SG001 and Fluorouracil
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteChina
Study dates: 1 Sep 2021to 16 Jan 2023
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

1. At least 18 years of age, regardless of gender. 2.Histologically or cytologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of biliary tract, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC) and gallbladder carcinoma (GBC).
3.At least one measurable lesion according to RECIST 1.1. 4.Previous first-line standard system chemotherapy failed. First-line standard chemotherapy is defined as gemcitabine combined with capecitabine or platinum.
5.Patients with prior local treatment (embolization, chemoembolization, radiofrequency ablation, or radical radiotherapy) must be completed at least 4 weeks before the first administration of the study drug, palliative decompensated radiotherapy (such as bone metastases) must be completed at least 2 weeks before the first administration of the study drug.
6.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 7.Life expectancy >3 months. 8.Adverse reactions must recover to grade 1 or baseline according to CTCAE 5.0 (except for toxicity such as alopecia, grade 2 or less sensory neuropathy, etc., which have been judged no safety risk by investigators).
9.Patients should not receive cell growth factors or blood and platelet transfusion within 7 days before the initiate administration of study drug, and laboratory test should meet the following criteria: neutrophile count ≥1.5×10^9/L;platelet count ≥90×10^9/L; hemoglobin ≥90 g/L or ≥5.6 mmol/L;serum creatinine ≤1.5×ULN or creatinine clearance rate must be ≥ 50 mL/min when serum creatinine >1.0×ULN;total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN or ≤2.5×ULN if intrahepatic lesions exist;Albumin ≥3 g/dL.
10. Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR) and prothrombin time (PT) ≤1.5 × ULN for patients not receiving therapeutic anticoagulation.

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11.Patients with biliary obstruction or no evidence of persistent infection should receive adequate biliary drainage; active or suspected infections are not allowed.
12. Female patients with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the study completion and have a negative serum pregnancy test within 7 days before enrollment, and must be non-lactating. Male patients must agree to use medically approved contraception during the study and for 6 months after the study period.
13. Ability to understand and the willingness to sign a written informed consent.

Who cannot join

1. Patients with definite positive NTRK fusion gene. 2. Patients who have received any investigational drug within 4 weeks prior to the first dose of irinotecan liposomes injection.
3. Patients with definite metastatic encephalopathy. 4. Patients who have received liver transplantation or liver metastases accounted for 50% or more of the total liver volume.
5. Patients with hepatic encephalopathy. 6. Uncontrolled third lacunar effusion other than ascites (e.g., large pleural or pericardial effusion).
7. Previous malignancies in the past five years (except radically resected and non-recurring basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or other carcinoma in situ).
8. History of serious cardiovascular disease. 9. Patients with uncontrolled active bleeding. 10. Gastrointestinal diseases of clinical significance, such as bleeding, inflammation, obstruction, >grade 1 diarrhea, etc.
11. Patients with definite Gilbert syndrome. 12. Patients who have concomitant use of strong CYP3A4 inducers within 2 weeks prior to the first dose, or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week prior to the first dose.

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13. Patients who received systemic glucocorticoids or other immunosuppressive agents within 14 days before the first dose of the study drug.
14. Patients who have undergone major organ surgery within 4 weeks prior to the first dose of the study drug.
15. Patients who are hypersensitivity to any component of irinotecan liposome injection or other liposome products.
16. Patients who are allergic to gemcitabine, cisplatin, fluorouracil or leucovorin or its components.
Additional exclusion criteria for cohort 2:
Patients who have received any other antibodies or drugs that act on T-cell synergetic stimulation or checkpoint pathways (including PD-1, PD-L1, CTLA-4 inhibitors, etc.).
Patients with a history of severe allergic reactions to monoclonal antibodies and uncontrolled allergic asthma.
Patients with active autoimmune disease or a history of autoimmune diseases.
History of primary immunodeficiency.
Patients who occurred immune related adverse events.
History of allogeneic organ or hematopoietic stem cell transplantation.
Received live attenuated vaccine within 14 days before screening period or planned to received it during the study period.

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

Read the detailed description

This is an open-label, parallel, multicentre, phase II study to evaluate the efficacy and safety of irinotecan liposome injection. Eligible patients will be divided into two cohorts according to the criteria for the corresponding cohort. The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV). The patients in cohort 2 will receive irinotecan liposome injection combined with a PD-1 inhibitor, 5-Fluorouracil and Leucovorin.

Conditions: Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
Being tested: Irinotecan Liposome Injection, SG001, Fluorouracil, Leucovorin
Medical subject headings: Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

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

Irinotecan Liposome InjectionDrug
Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL
SG001Drug
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL
FluorouracilDrug
5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle
LeucovorinDrug
Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle

Study groups in NCT05009953
Study group	Role	What they receive
Cohort 1: Irinotecan Liposome Injection + 5-FU/LV	Experimental	The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or termination of the study for other reasons. Receives: Drug: Irinotecan Liposome Injection; Drug: Fluorouracil; Drug: Leucovorin
Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV	Experimental	The patients in cohort 1 will receive irinotecan liposome injection combined with SG001, 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or until 24 months is reached, or the study is terminated for other reasons. Receives: Drug: Irinotecan Liposome Injection; Drug: SG001; Drug: Fluorouracil; Drug: Leucovorin

What is being measured

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

Objective Response Rate (ORR)
The percentage of patients who achieve a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Measured: Up to six months after the last patient's first administration

Secondary outcomes (8)

Progression-Free Survival (PFS)
Time from date of the first dose to date of recorded disease progression or death, whichever occurs first
Measured: Up to six months after the last patient's first administration
Overall survival (OS)
Time from date of the first dose to date of death from any cause
Measured: Up to six months after the last patient's first administration
Disease Control Rate (DCR)
The percentage of patients who achieve a CR, PR or stable disease (SD) based on the RECIST 1.1
Measured: Up to six months after the last patient's first administration
Duration of Response (DOR)
Time from first documented response (CR or PR whichever occurs first, based on investigator's assessment per RECIST 1.1) to date of disease progression or death due to any cause, whichever occurs first
Measured: Up to six months after the last patient's first administration
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)
The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0
Measured: Up to six months after the last patient's first administration
Peak Plasma Concentration
Cmax
Measured: 0-240 h of circle 1 to circle 4
Area under the plasma concentration versus time curve
AUC
Measured: 0-240 h of circle 1 to circle 4
UGT1A1
UGT1A1 gene polymorphism
Measured: Within 3 days before the first dose

Timeline

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

1 Sep 202116 Jan 2023

First posted18 Aug 2021
Study start1 Sep 2021
Primary completion16 Jan 2023
Study completion16 Jan 2023

Why it stopped: Internal strategy change. Not related to safety concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05009953
Sponsor's protocol ID: HE072-CSP-003
Status last verified: Jun 2024
First submitted: 4 Aug 2021
Last updated: 11 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma

All Advanced Biliary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT05009953
Acronym / sponsor ID: HE072-CSP-003
Conditions: Advanced Biliary Tract Cancer, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Internal strategy change. Not related to safety concerns.
Enrolment: 17 participants (actual)
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Sep 2021 (actual)
Primary completion: 16 Jan 2023 (actual)
Study completion: 16 Jan 2023 (actual)
First posted: 18 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Irinotecan Liposome Injection + 5-FU/LV	Experimental	Drug: Irinotecan Liposome Injection, Drug: Fluorouracil, Drug: LeucovorinThe patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or termination of the study for other reasons.
Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV	Experimental	Drug: Irinotecan Liposome Injection, Drug: SG001, Drug: Fluorouracil, Drug: LeucovorinThe patients in cohort 1 will receive irinotecan liposome injection combined with SG001, 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or until 24 months is reached, or the study is terminated for other reasons.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

1. At least 18 years of age, regardless of gender. 2.Histologically or cytologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of biliary tract, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC) and gallbladder carcinoma (GBC).
3.At least one measurable lesion according to RECIST 1.1. 4.Previous first-line standard system chemotherapy failed. First-line standard chemotherapy is defined as gemcitabine combined with capecitabine or platinum.
5.Patients with prior local treatment (embolization, chemoembolization, radiofrequency ablation, or radical radiotherapy) must be completed at least 4 weeks before the first administration of the study drug, palliative decompensated radiotherapy (such as bone metastases) must be completed at least 2 weeks before the first administration of the study drug.
6.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 7.Life expectancy >3 months. 8.Adverse reactions must recover to grade 1 or baseline according to CTCAE 5.0 (except for toxicity such as alopecia, grade 2 or less sensory neuropathy, etc., which have been judged no safety risk by investigators).
9.Patients should not receive cell growth factors or blood and platelet transfusion within 7 days before the initiate administration of study drug, and laboratory test should meet the following criteria: neutrophile count ≥1.5×10^9/L;platelet count ≥90×10^9/L; hemoglobin ≥90 g/L or ≥5.6 mmol/L;serum creatinine ≤1.5×ULN or creatinine clearance rate must be ≥ 50 mL/min when serum creatinine >1.0×ULN;total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN or ≤2.5×ULN if intrahepatic lesions exist;Albumin ≥3 g/dL.

Key exclusion criteria (18 listed)

1. Patients with definite positive NTRK fusion gene. 2. Patients who have received any investigational drug within 4 weeks prior to the first dose of irinotecan liposomes injection.
3. Patients with definite metastatic encephalopathy. 4. Patients who have received liver transplantation or liver metastases accounted for 50% or more of the total liver volume.
5. Patients with hepatic encephalopathy. 6. Uncontrolled third lacunar effusion other than ascites (e.g., large pleural or pericardial effusion).
7. Previous malignancies in the past five years (except radically resected and non-recurring basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or other carcinoma in situ).
8. History of serious cardiovascular disease. 9. Patients with uncontrolled active bleeding. 10. Gastrointestinal diseases of clinical significance, such as bleeding, inflammation, obstruction, >grade 1 diarrhea, etc.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Irinotecan Liposome InjectionIrinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL	Drug	Cohort 1: Irinotecan Liposome Injection + 5-FU/LV, Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV
SG001Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL	Drug	Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV
Fluorouracil5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle	Drug	Cohort 1: Irinotecan Liposome Injection + 5-FU/LV, Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV
LeucovorinLeucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle	Drug	Cohort 1: Irinotecan Liposome Injection + 5-FU/LV, Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV

Primary outcome

Objective Response Rate (ORR)
Time frame: Up to six months after the last patient's first administration
The percentage of patients who achieve a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

8 secondary outcomes

Progression-Free Survival (PFS)
Time frame: Up to six months after the last patient's first administration
Overall survival (OS)
Time frame: Up to six months after the last patient's first administration
Disease Control Rate (DCR)
Time frame: Up to six months after the last patient's first administration
Duration of Response (DOR)
Time frame: Up to six months after the last patient's first administration
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to six months after the last patient's first administration
Peak Plasma Concentration
Time frame: 0-240 h of circle 1 to circle 4
Area under the plasma concentration versus time curve
Time frame: 0-240 h of circle 1 to circle 4
UGT1A1
Time frame: Within 3 days before the first dose

Results and safety

The study was stopped early (reason given: Internal strategy change. Not related to safety concerns.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Individual participant dataSharing planned: No

Related trials for Advanced Biliary Tract Cancer

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiangdong Cheng principal investigator

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 stopped early (reason given: Internal strategy change. Not related to safety concerns.). Results are not available in the source record.

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 (ORR) (time frame: Up to six months after the last patient's first administration). 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 NCT05009953.

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 11 Jul 2024.