Irinotecan Liposomes +5-FU/LV Versus Capecitabine in Patients of Recurrence After Resection of Resectable BTC

NCT06699459 | Not Yet Recruiting Phase 2

• 1 other identifier: SRRSH.20240559
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Biliary Tract Carcinoma

Keywords

Biliary Tract Carcinoma; Adjuvant treatment; Resectable; Irinotecan liposomes; Capecitabine

Outcome Measures

Primary Outcomes (1)

• one year DFS rate

  The percentage of patients free of disease when the disease-free survival is at the 1-year node

  From date of randomization until the date of one year

Secondary Outcomes (4)

• Progression free survival

  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

  From date of randomization until the date of death from any cause, assessed up to 24 months

• Disease-free survival

  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 up to 24 months

Study Arms (2)

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;

Drug: Irinotecan Liposome

Capecitabine

OTHER

Capecitabine, 1250mg/m2 oral, bid, Q3W, d1-14;

Drug: Capecitabine

Interventions

Irinotecan Liposome DRUG

②LV: 400mg/m2, intravenous infusion, Q2W, d1; ③5-FU: 2400 mg/m2, continuous intravenous infusion, Q2W, d1-2;

Also known as: Irinotecan Liposome+LV/5-FU

Irinotecan liposome

Capecitabine DRUG

① Capecitabine, 1250mg/m2 orally, bid, Q3W, d1-14;

Capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Zhejiang Cancer Hospital: collaborator
• RenJi Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Fujian Provincial Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator
• Shaoxing People's Hospital: collaborator
• Southern Medical University, China: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (6)

Fujian Provincial Hospital

Fuzhou, Fujian, 350028, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

irinotecan sucrosofate; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mingyu Chen, Ph.D

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyu Chen, Ph.D

CONTACT

0086-18757772223; mychen@zju.edu.cn

Ruijing Shen, Master

CONTACT

0086-17706431287; 22418542@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 21, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)