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

March 30, 2023 updated by: chengxiaojiao, RenJi Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will include patients with advanced duodenal adenocarcinoma who received third-line or above treatment with the combination of furquimatinib and sintilimab in Renji Hospital from January 2019 to the present.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary efficacy endpoint: Objective Response Rate (ORR)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ-FC-ADA-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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