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

Overall Survival Clinical Trial

Official title:

Phase 2 Study of Anlotinib With PD-1 Inhibitor as Second Line Therapy in the Treatment of Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218629
• Other study ID #: QDCH2022-01-18
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2023
• Source: Qingdao Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites. • Other histologies such as neuroendocrine and acinar cell carcinoma are excluded. Enrolled patients are all failed to first-line chemotherapy • Patients are eligible if they received adjuvant treatment after surgical resection • Participants are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. See section 11 for the evaluation of measurable disease. • Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy.
• Age = 18 years. Because no dosing or adverse event data are currently available in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials. • ECOG performance status =2 (see Appendix A) • Patients must have completed any major surgery or open biopsy =4 weeks from start of treatment. • Participants must have adequate organ and marrow function as defined below: o Absolute neutrophil count =1,500/mcL o Platelets =100,000/mcL o Total bilirubin =1.5 × institutional upper limit of normal o AST(SGOT)/ALT(SGPT) =2.5 × institutional upper limit of normal o Creatinine =1.5 × institutional upper limit of normal OR o Creatinine clearance =60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal. • Negative serum pregnancy test for women of childbearing potential. • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents. • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Screening for brain metastases with head imaging is not required. • History of allergic reactions attributed to compounds of similar chemical or biologic composition to above drugs or other agents used in study. • History of prior or current synchronous malignancy, except: o Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, NYHA class III/IV congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Related Conditions & MeSH terms

• Overall Survival

Intervention

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

Locations

Country	Name	City	State
China	Qingdao central Hospital	Qingdao	Shandong
China	Qingdao central Hospital	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall survival in this population of patients	The overall survival of the enrolled patients from start the combination treatment of anlotinib and PD-1 inhibitor	24 months
Secondary	The progression free survival in this population of patients	The progression free survival of the enrolled patients from start the combination treatment with anlotinib and PD-1 inhibitor	24 months
Secondary	The response rate in this population of patients	Number of participants with clinical response assessed by RECIST 1.1 criteria on imaging every 4 weeks with the combination of anlotinib and PD-1 inhibitor	Up to 48 months