Combining Anlotinib and PD-1 Inhibitor for Advanced Pancreatic Cancer
Phase 2 Study of Anlotinib With PD-1 Inhibitor as Second Line Therapy in the Treatment of Metastatic Pancreatic Cancer
This study is testing if combining a new oral medication with an immune therapy can help people with advanced pancreatic cancer who didn't respond to their first treatment live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qingdao Central Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Anlotinib |
| Locations | 2 sites (Qingdao, Shandong and 1 other locations) |
| Trial ID | NCT05218629 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial investigates the safety and efficacy of Anlotinib, a small molecular anti-VEGF TKI, in combination with a PD-1 inhibitor as a second-line treatment for patients with metastatic pancreatic adenocarcinoma who have failed first-line chemotherapy. Participants will receive Anlotinib orally for 14 days and the PD-1 inhibitor intravenously every 21 days, continuing until intolerable side effects occur, disease progression, or study discontinuation. The primary goal is to evaluate overall survival in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage 4 untreated metastatic pancreatic ductal cancer who have failed first-line chemotherapy.
Not a fit: Patients with other histologies of pancreatic cancer, such as neuroendocrine or acinar cell carcinoma, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could improve overall survival rates for patients with advanced pancreatic cancer.
How similar studies have performed: While this approach is novel in the context of metastatic pancreatic cancer, similar combinations have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Qingdao, Shandong and 1 other locations
- Qingdao central Hospital — Qingdao, Shandong, China (Recruiting)
- Qingdao central Hospital — Qingdao, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.