Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

NCT05697237 | Unknown

• 1 other identifier: XJTU1AF2021LSK-368
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine combined with cisplatin (GC) is the standard first-line treatment for patients with advanced biliary carcinoma, and up to now there is no standard second-line treatment Commend.Carrilizumab was highly effective in previous studies,Its combined GEMOX protocol has been published in the "Guidelines for the Diagnosis and Treatment of Gallbladder Cancer (2019 Edition)" and the "China Clinical Oncology" The Society's (CSCO) Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancers.Solfantinib is targeted at VEGFR1, 2, 3, FGFR1And CSF1R highly selective small molecule targeted therapy drugs. Data from a preliminary phase 2 clinical trial observed sofantinib therapy Survival benefits of cholangiocarcinoma patients in China.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival

  6months

Secondary Outcomes (3)

• ORR

  6months

• OS

  12months

• DCR

  6months

Study Arms (1)

Advanced or metastatic cholangiocarcinoma

EXPERIMENTAL

In this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles.

Drug: Carrelizumab; Drug: Solfantinib

Interventions

Carrelizumab DRUG

Carrelizumab 200mg/3 weeks

Advanced or metastatic cholangiocarcinoma

Solfantinib DRUG

Solfantinib 300mg/d

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:

• Advanced inability to root was pathologically confirmed Patients with curatively resected or metastatic bile duct epithelial cell carcinoma;
• had previously received systemic antitumor therapy with a chemotherapy regimen (including gemcitabine)
• Age ≥18 and under 75
• 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 allergies to carrilizumab or solfantinib machine components
• Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5 times of normal value 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, cervical cancer in situ)
• 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 take appropriate contraceptive measures during the course of the 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

camrelizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• enxiao li, PHD

  First hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yangwei fan, phd

CONTACT

+8615029078171; 1159950306@qq.com

rui qu

CONTACT

+18681943306; 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 21, 2022
• First Posted: January 25, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 25, 2023

Record last verified: 2022-12