Combination treatment for advanced metastatic pancreatic cancer
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study
This study is testing a new combination of four cancer drugs to see if it helps people with advanced pancreatic cancer live longer and feel better compared to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 177 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Drugs / interventions | anlotinib, Penpulimab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06051851 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination therapy involving Penpulimab, Anlotinib, Nab-paclitaxel, and Gemcitabine as a first-line treatment for patients with advanced metastatic pancreatic cancer. It is a multi-center, open-label, randomized controlled Phase II study that aims to compare this combination therapy against a standard treatment regimen. The study will assess various efficacy indicators, including median progression-free survival and overall survival, while also monitoring safety and tolerability. Patients will be closely monitored for treatment response and adverse events throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic pancreatic adenocarcinoma who have not previously received systemic anti-cancer therapy.
Not a fit: Patients with severe comorbidities or those who have previously undergone systemic anti-cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced metastatic pancreatic cancer.
How similar studies have performed: While there have been studies exploring similar combination therapies, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages ≥18 years，ECOG ≤ 2，Estimated survival time \> 3 months * Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma * Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion * Patients have never received systematical anti-cancer therapy * Laboratory examination meets the following requirements: White blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥90g/L; platelet count(PLT) ≥75×109/L; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml/min; * Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \> 50% * Patients of childbearing age should take appropriate protective measures before enrollment and during the trial * Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up * Ability to follow the study protocol and follow-up procedures. Exclusion Criteria: * Patients have ever received any systematical anti-cancer therapy in the past * Patients who participated in other clinical trials in the past 4 weeks * According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator) * Patients with moderate ascites requiring drainage * Patients with CNS metastases and/or carcinomatous meningitis * Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence; * Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs * Patients with bleeding tendency. * Pregnant or lactating women. * Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study * Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine
Where this trial is running
Nanjing, Jiangsu
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Juan Du — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study coordinator: Juan Du
- Email: dujuanglyy@163.com
- Phone: +0086-13951826526
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.