Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab

Not yet recruiting

• Conditions: Dvanced Duodenal Adenocarcinoma; Furquinelone Combined With Sintilimab; Third-line Treatment

• Registration Number: NCT05810142
• Lead Sponsor: RenJi Hospital

Brief Summary

This research project is a single-center, retrospective clinical exploration study. It aims to retrospectively analyze data from 20 patients with advanced duodenal adenocarcinoma who received third-line treatment with furquinelone combined with sintilimab, in order to determine the clinical efficacy and safety of this combination therapy in advanced duodenal cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Study Start: 2023-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients must meet all of the following criteria to be eligible for inclusion:

Age between 18 and 80 years (inclusive); Imaging findings consistent with unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; Histologically confirmed unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; ECOG performance status 0-2; At least one measurable or evaluable lesion according to RECIST v1.1; Third-line or above treatment with the combination of sintilimab and furquimatinib.

Exclusion Criteria

Patients meeting any of the following criteria will be excluded:

Patients with incomplete clinical data or laboratory examination that affects statistical analysis; Patients who have had other malignant tumors in the past 5 years; Patients who have had arterial thrombotic diseases such as angina, myocardial infarction, and transient ischemic attack in the past 6 months; Patients who have received other types of anti-tumor or experimental treatment; Pregnant or lactating women; Patients with other diseases or abnormal mental status that may affect the patient's treatment; Patients who have received other types of immune therapy, anti-angiogenic drugs, or small-molecule tyrosine kinase inhibitors.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint: Objective Response Rate (ORR)	2 years