Advanced or Metastatic Cholangiocarcinoma

NCT05653817 | Unknown

• 1 other identifier: XJTU1AF2021LSK-062
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, open, multicenter trial of carralizumab in combination with albumin paclitaxel and apatinib mesylate for the second-line treatment of patients with advanced or metastatic cholangiocarcinoma. The study enlists patients with histopathologically or cytologically confirmed unresectable, recurrent, or metastatic cholangiocarcinoma (including intrahepatic, extrahepatic, and distal cholangiocarcinoma). Previously, she had received systematic internal medicine anti-tumor therapy with gemcitabine regimen as standard, which met the inclusion criteria of this study. She was given oral therapy with albumin binding paclitaxel combined with carrilizumab and apatinib mesylate. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen. To evaluate progression-free survival (PFS) in second-line therapy with carrilizumab in combination with albumin paclitaxel and apatinib mesylate in patients with advanced or metastatic cholangiocarcinoma.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  24month

Secondary Outcomes (1)

• OS

  24month

Study Arms (1)

Advanced or metastatic cholangiocarcinoma

EXPERIMENTAL

A multicenter clinical study of carralizumab combined with albumin paclitaxel and apatinib mesylate in the second-line treatment of advanced or metastatic cholangiocarcinoma.Albumin-bound paclitaxel 125 mg/m2 d1,8; Carrilizumab 200mg Q3W d1; Apatinib mesylate tablet treatment: 250mg orally, once a day, continuous administration. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen.

Drug: Carrilizumab; Drug: Albumin-bound paclitaxel; Drug: Apatinib

Interventions

Carrilizumab DRUG

Carrilizumab 200mg Q3W d1

Advanced or metastatic cholangiocarcinoma

Albumin-bound paclitaxel DRUG

Albumin-bound paclitaxel 125 mg/m2 d1,8

Advanced or metastatic cholangiocarcinoma

Apatinib DRUG

Apatinib mesylate tablets for treatment: 250mg

Advanced or metastatic cholangiocarcinoma

Eligibility Criteria

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

You may qualify if:

• Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma;
• Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel;
• Age ≥18 years old and under 75 years old;
• Predicted survival ≥3 months;
• ECOG score 0-1;
• Child-Pugh score\<8
• There was at least one measurable tumor lesion with a long diameter ≥10 mm and a short diameter ≥15 mm on spiral CT. For general CT or physical examination, the maximum diameter must be ≥20mm;
• The results of liver and kidney function and blood routine examination within 1 week before enrollment were consistent with the following conditions， ANC≥1.5×10\^9/L,PLT≥80×10\^9/L,HGB≥80g/L,Cr≤1.5×ULN,TBIL≤2.5×ULN,ALP≤2.5×ULN,AST≤2.5×ULN,ALT≤2.5×ULN
• Patients participate voluntarily and sign informed consent forms

You may not qualify if:

• Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel;
• Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention;
• Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
• Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency;
• History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix);
• Interstitial pneumonia or pulmonary fibrosis;
• Uncontrollable pleural effusion or ascites;
• Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months);
• Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study;
• The researchers determined that the patients were not suitable for this study.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Albumin-Bound Paclitaxel; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• enxiao li, PHD

  First hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yangwei fan, phd

CONTACT

+8615029078171; 1289271841@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 16, 2022
• Study Start: January 31, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 16, 2022

Record last verified: 2022-12