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Anlotinib Plus PD-1 Inhibitor as 2nd-line Threapy in Patients With Metastatic Pancreatic Cancer

NCT05218629 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-29

No results posted yet for this study

Summary

This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug of Anlotinib (a small molecular anti-VEGF TKI) with PD-1 inhibitor in second-line therapy with the goal of determining the OS of metastatic pancreatic adenocarcinoma. Subjects must have a stage 4 untreated metastatic pancreatic ductal cancer failed to first-line chemotherapy and meet all inclusion/exclusion criteria. Treatment consists of treatment with anlotinib 8-12 mg oral, day 1-14, and PD-1 inhibitor 200 mg iv, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.

Conditions

  • Overall Survival

Interventions

DRUG

Anlotinib, PD-1 inhibitor

Anlotinib, 8-12 mg/day, orally, day 1-14; PD-1 inhibitor 200 mg iv, every 21 days one cycle

Sponsors & Collaborators

  • Qingdao Central Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218629 on ClinicalTrials.gov