Advanced or Metastatic Cholangiocarcinoma

NCT ID: NCT05653817

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2026-01-31

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.

Detailed Description

Cholangiocarcinoma (CCA) is a cancer that easily invades adjacent structures. Vascular endothelial growth factor (VEGF) and VEGF receptor 2 (VEGFR2) are increased in most types of cancer and inhibit tumor progression by blocking VEGF/VEGFR2 [16]. Apatinib is a highly selective VEGFR2 antagonist that inhibits apoptosis and growth of CCA cells. Apatinib is also a derivative of PTK787, and its targets include VEGFR-1, VEGFR-2, PDGFR, c-kit, c-Src, etc. The activity of Apatinib against VEGFR-2 is 137 times that of PTK787, the IC50 is only 1nmol/L, and it can strongly inhibit tumor angiogenesis. At the same time, it can also inhibit the downstream signal transduction mediated by KDR and inhibit tumor growth.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advanced or metastatic cholangiocarcinoma

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.

Group Type: EXPERIMENTAL

Carrilizumab

Intervention Type: DRUG

Carrilizumab 200mg Q3W d1

Albumin-bound paclitaxel

Intervention Type: DRUG

Albumin-bound paclitaxel 125 mg/m2 d1,8

Apatinib

Intervention Type: DRUG

Apatinib mesylate tablets for treatment: 250mg

Interventions

Carrilizumab

Carrilizumab 200mg Q3W d1

Intervention Type: DRUG

Albumin-bound paclitaxel

Albumin-bound paclitaxel 125 mg/m2 d1,8

Intervention Type: DRUG

Apatinib

Apatinib mesylate tablets for treatment: 250mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma;

2. Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel;

3. Age ≥18 years old and under 75 years old;

4. Predicted survival ≥3 months;

5. ECOG score 0-1;

6. Child-Pugh score<8

7. 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;

8. 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

9. Patients participate voluntarily and sign informed consent forms

Exclusion Criteria

1. Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel;

2. Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention;

3. Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;

4. Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency;

5. History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix);

6. Interstitial pneumonia or pulmonary fibrosis;

7. Uncontrollable pleural effusion or ascites;

8. Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months);

9. Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study;

10. The researchers determined that the patients were not suitable for this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

enxiao li, PHD

Role: PRINCIPAL_INVESTIGATOR

First hospital of Xi'an Jiaotong University

Central Contacts

yangwei fan, phd

Role: CONTACT

Phone: +8615029078171

Email: 1289271841@qq.com

Other Identifiers

XJTU1AF2021LSK-062

Identifier Type: -

Identifier Source: org_study_id