Biliary Tract CarcinomaPhase 2NICRRBTCNCT06699459
Irinotecan Liposomes +5-FU/LV Versus Capecitabine in Patients of Recurrence After Resection of Resectable BTC
A Phase 2 study testing Irinotecan Liposome and Capecitabine in people with Biliary Tract Carcinoma, run by Sir Run Run Shaw Hospital at 6 sites in China.
Trial summary
Irinotecan liposome combined with 5-FU/LV has shown good efficacy and has certain advantages in reducing the adverse reactions of conventional chemotherapy drugs. Adjuvant treatment of high-risk factors after surgery for biliary tract tumors can be further explored and attempted. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Carcinoma
- What is being tested?
- Irinotecan Liposome and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 6 sitesChina
- Study dates
- 14 Nov 2024to 15 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old.
- Patients with histologically confirmed, resectable biliary malignancies with R0 resection.
- Postoperative pathology indicated the following risk factors: positive lymph nodes, vascular invasion, nerve invasion and so on.
- Has not received systemic chemotherapy before.
- The ECOG score is 0 to 1.
- Bone marrow and organ function were good: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5× upper limit of normal range (ULN), ≤5×ULN with liver metastasis; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL/min (calculated according to Cockroft-Gault).
- Expected survival ≥3 months.
- Volunteer to participate in the study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent.
Who cannot join
- Patients allergic to the investigational drug and its excipients.
- Known or suspected central nervous system or lymphatic metastasis.
- Cannot discontinue use or has not discontinued use of CYP3A, CYP2C8, and UGT1A1 potent depressants or inducers (e.g., anticonvulsants [phenytoin, phenobarbital, or carbamazepine] within 2 weeks prior to enrollment), rifampicin, rifambutin, St.John's Wort, Grapefruit juice, clarithromycin, Itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, Indinavir, etc.).
- There are signs and symptoms of intestinal obstruction.
- Other malignancies within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancers.
- Autoimmune disease or long-term steroid use.
Show all 9Show fewer
- Patients who are pregnant or nursing women, and patients who refuse to receive contraception during their reproductive age.
- Patients deemed unsuitable for participation in this study.
- Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, etc.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Fujian Provincial Hospital
Fuzhou, Fujian, 350028
Shi Chen
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Wei Chen
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Yuhua Zhang, Ph.D
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Mingyu Chen, Ph.D, 0086-18757772223, mychen@zju.edu.cn
Ruijing Shen, Master, 0086-17706431287, 22418542@zju.edu.cn
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
Maolang Li, Ph.D
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Xiangsong Wu
About this study
Official title: Irinotecan Liposomes +5-FU/LV or Capecitabine in Patients at High Risk of Recurrence After Resection of Resectable Biliary Tract Carcinoma: A Prospective Phase II Study
Irinotecan liposome combined with 5-FU/LV has shown good efficacy and has certain advantages in reducing the adverse reactions of conventional chemotherapy drugs. Adjuvant treatment of high-risk factors after surgery for biliary tract tumors can be further explored and attempted. Therefore, this study intends to conduct an exploratory study comparing oral capecitabine with irinotecan liposome +5-FU/LV for adjuvant therapy in high-risk patients after resection of resectable biliary malignancies, and evaluate the effectiveness and safety of irinotecan liposome +5-FU/LV as adjuvant therapy for high-risk patients after resection of resectable biliary malignancies. So it can provide more treatment options for patients with postoperative adjuvant therapy of biliary tract malignant tumor.
The DFS rate one year after surgery for biliary malignancy was assumed to be 51.4% with a maximum response rate of poor efficacy and 71.4% with a minimum response rate of good efficacy. A two-stage design was adopted with α=0.05 and certainty (1-β) =0.8, and Minimax was adopted. If a response occurs in 7 out of 14 patients or less, treatment options are rejected; In the second phase, if 24 or fewer responses occur in 38 patients, the protocol is rejected. A total of 38 samples were designed in two stages. The 1-year DFS rate was at least 65.8% in the total population of the test and control groups.
Read the detailed description
According to the 2023 CSCO guidelines, differentiated surgical treatment has been performed for the site of biliary malignancies. For postoperative adjuvant therapy, BILCAP study showed that oral capecitabine as a single drug is one of the options for both efficacy and safety. For patients with postoperative risk factors, serum carcinoembryonic antigen (CEA) and CA19-9 are of some significance for monitoring recurrence, and often serve as precursors for clinical judgment of recurrence or progression. For people with high risk factors for recurrence and progression, adjuvant therapy intensity needs to be strengthened. Oral capecitabine can no longer meet the needs of this population, so patients need to be given intravenous chemotherapy in advance to control progression, recurrence or metastasis. In this case, metastatic first-line therapy is often used for early intervention. The NIFE study showed that compared with conventional chemotherapy regimens, the regimen of irinotecan liposome (new formulation) combined with 5-FU/LV achieved relatively better efficacy data in the median OS and ORR efficacy. It is noteworthy that this regimen has a significant therapeutic benefit in patients with advanced first-line extrahepatic cholangiocarcinoma, with a median PFS of 9.59 months and a median OS of 18.23 months.
To explore the efficacy and safety of irinotecan liposomes +5-FU/LV versus oral capecitabine in patients at high risk of recurrence after resection of resectable biliary malignancies.
- Conditions
- Biliary Tract Carcinoma
- Being tested
- Irinotecan Liposome, Capecitabine
- Keywords
- Biliary Tract Carcinoma, Adjuvant treatment, Resectable, Irinotecan liposomes, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan LiposomeDrug
Also called Irinotecan Liposome+LV/5-FU
②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2;
CapecitabineDrug
① Capecitabine, 1250mg/m2 orally, bid, Q3W, d1-14;
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome | Experimental | * Irinotecan liposomes: 70mg/m2, intravenous infusion, Q2W, d1; ②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2; Receives: Drug: Irinotecan Liposome |
| Capecitabine | Other | Capecitabine, 1250mg/m2 oral, bid, Q3W, d1-14; Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year DFS rate
The percentage of patients free of disease when the disease-free survival is at the 1-year node
Measured: From date of randomization until the date of one year
Secondary outcomes (4)
Progression free survival
Time from initiation of treatment to first recording of PD or death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
The time between the start of treatment and the first recorded death
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months
Disease-free survival
From randomization to the time when the first tumor recurred or metastasized, or when the subject died for any reason
Measured: From date of randomization until the date of first tumor recurred or metastasized or date of death from any cause, whichever came first, assessed up to 24 months
adverse events
Incidence and severity of adverse events in treatment regimens
Measured: Incidence and severity of adverse events in treatment regimens up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start14 Nov 2024 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fujian Provincial Hospital, Ningbo No. 1 Hospital, Shaoxing People's Hospital, Southern Medical University, China, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Mingyu Chen, Ph.D, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699459
- Sponsor's protocol ID
- SRRSH.20240559
- Acronym
- NICRRBTC
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Decide whether to share research data after publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Liposomes +5-FU/LV or Capecitabine in Patients at High Risk of Recurrence After Resection of Resectable Biliary Tract Carcinoma: A Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT06699459
- Acronym / sponsor ID
- NICRRBTC / SRRSH.20240559
- Conditions
- Biliary Tract Carcinoma
- Keywords
- Biliary Tract Carcinoma, Adjuvant treatment, Resectable, Irinotecan liposomes, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fujian Provincial Hospital, Ningbo No. 1 Hospital, Shaoxing People's Hospital, Southern Medical University, China, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 14 Nov 2024 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 21 Nov 2024 (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.
Irinotecan liposome combined with 5-FU/LV has shown good efficacy and has certain advantages in reducing the adverse reactions of conventional chemotherapy drugs. Adjuvant treatment of high-risk factors after surgery for biliary tract tumors can be further explored and attempted. Therefore, this study intends to conduct an exploratory study comparing oral capecitabine with irinotecan liposome +5-FU/LV for adjuvant therapy in high-risk patients after resection of resectable biliary malignancies, and evaluate the effectiveness and safety of irinotecan liposome +5-FU/LV as adjuvant therapy for high-risk patients after resection of resectable biliary malignancies. So it can provide more treatment options for patients with postoperative adjuvant therapy of biliary tract malignant tumor.
The DFS rate one year after surgery for biliary malignancy was assumed to be 51.4% with a maximum response rate of poor efficacy and 71.4% with a minimum response rate of good efficacy. A two-stage design was adopted with α=0.05 and certainty (1-β) =0.8, and Minimax was adopted. If a response occurs in 7 out of 14 patients or less, treatment options are rejected; In the second phase, if 24 or fewer responses occur in 38 patients, the protocol is rejected. A total of 38 samples were designed in two stages. The 1-year DFS rate was at least 65.8% in the total population of the test and control groups.
Detailed description
According to the 2023 CSCO guidelines, differentiated surgical treatment has been performed for the site of biliary malignancies. For postoperative adjuvant therapy, BILCAP study showed that oral capecitabine as a single drug is one of the options for both efficacy and safety. For patients with postoperative risk factors, serum carcinoembryonic antigen (CEA) and CA19-9 are of some significance for monitoring recurrence, and often serve as precursors for clinical judgment of recurrence or progression. For people with high risk factors for recurrence and progression, adjuvant therapy intensity needs to be strengthened. Oral capecitabine can no longer meet the needs of this population, so patients need to be given intravenous chemotherapy in advance to control progression, recurrence or metastasis. In this case, metastatic first-line therapy is often used for early intervention. The NIFE study showed that compared with conventional chemotherapy regimens, the regimen of irinotecan liposome (new formulation) combined with 5-FU/LV achieved relatively better efficacy data in the median OS and ORR efficacy. It is noteworthy that this regimen has a significant therapeutic benefit in patients with advanced first-line extrahepatic cholangiocarcinoma, with a median PFS of 9.59 months and a median OS of 18.23 months.
To explore the efficacy and safety of irinotecan liposomes +5-FU/LV versus oral capecitabine in patients at high risk of recurrence after resection of resectable biliary malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome | Experimental | Drug: Irinotecan Liposome* Irinotecan liposomes: 70mg/m2, intravenous infusion, Q2W, d1; ②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2; |
| Capecitabine | Other | Drug: CapecitabineCapecitabine, 1250mg/m2 oral, bid, Q3W, d1-14; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old.
- Patients with histologically confirmed, resectable biliary malignancies with R0 resection.
- Postoperative pathology indicated the following risk factors: positive lymph nodes, vascular invasion, nerve invasion and so on.
- Has not received systemic chemotherapy before.
- The ECOG score is 0 to 1.
Key exclusion criteria (9 listed)
- Patients allergic to the investigational drug and its excipients.
- Known or suspected central nervous system or lymphatic metastasis.
- Cannot discontinue use or has not discontinued use of CYP3A, CYP2C8, and UGT1A1 potent depressants or inducers (e.g., anticonvulsants [phenytoin, phenobarbital, or carbamazepine] within 2 weeks prior to enrollment), rifampicin, rifambutin, St.John's Wort, Grapefruit juice, clarithromycin, Itraconazole, Lopinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Terrapivir, voriconazole, Azanavir, Gefilozil, Indinavir, etc.).
- There are signs and symptoms of intestinal obstruction.
- Other malignancies within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancers.
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 LiposomeAlso: Irinotecan Liposome+LV/5-FU②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2; | Drug | Irinotecan liposome |
| Capecitabine① Capecitabine, 1250mg/m2 orally, bid, Q3W, d1-14; | Drug | Capecitabine |
Primary outcome
one year DFS rate
Time frame: From date of randomization until the date of one year
The percentage of patients free of disease when the disease-free survival is at the 1-year node
4 secondary outcomes
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months
Disease-free survival
Time frame: From date of randomization until the date of first tumor recurred or metastasized or date of death from any cause, whichever came first, assessed up to 24 months
adverse events
Time frame: Incidence and severity of adverse events in treatment regimens up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. Decide whether to share research data after publication
Related trials for Biliary Tract Carcinoma
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
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
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.
Mingyu Chen, Ph.D principal investigator
Sir Run Run Shaw Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan Liposome and Capecitabine in people with Biliary Tract Carcinoma, run by Sir Run Run Shaw Hospital at 6 sites in China.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyu Chen, Ph.D (0086-18757772223, mychen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year DFS rate (time frame: From date of randomization until the date of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.