Combination of PD-1 antibody and Sapropterin for advanced pancreatic cancer
The Efficacy and Safety of PD-1 Antibody Combined With Sapropterin Dihydrochloride in Patients With Advanced Pancreatic Cancer Who Failed to Standard Treatment.
This study is testing a new combination of two treatments for people with advanced pancreatic cancer who haven't had success with regular chemotherapy to see if it can help them feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Sintilimab, chemotherapy, prednisone, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06396637 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining Sapropterin Dihydrochloride with a PD-1 antibody in patients with metastatic pancreatic adenocarcinoma who have not responded to standard chemotherapy treatments. The study aims to enroll 20 participants who will receive this combination therapy, with the primary focus on measuring the objective response rate and safety of the treatment. Secondary endpoints include overall survival, progression-free survival, and quality of life assessments. The trial is designed to provide insights into alternative treatment options for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically confirmed metastatic pancreatic ductal adenocarcinoma who have failed or cannot tolerate standard chemotherapy.
Not a fit: Patients who are currently pregnant, lactating, or have a known allergy to the study drugs will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced pancreatic cancer who have exhausted standard treatment options.
How similar studies have performed: While immunotherapy approaches have shown limited success in pancreatic cancer, this specific combination treatment is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC). * Recurrent disease or metastatic disease evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary. * Fail or could not tolerate standard chemotherapy. * ECOG score 0 or 1. * Have measurable target lesion. * Serum total bilirubin level is less than 1.5 x ULN. ALT and AST are less than 2 x ULN. Hemoglobin≥9g/dL, platelet≥75×10\*9/L, white blood count ≥3.0×10\*9/L, neutrophil ≥1.5×10\*9/L. Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 60 mL/min. * Signed informed consent. Exclusion Criteria: * History of participation of other clinical trials within 4 weeks * Known or suspected allergy to Sintilimab or tetrahydrobiopterin. * Female patients during pregnancy or lactation. * Patients who lack the ability to provide informed consent due to psychological, family, social, or other factors. * Patients with a history of other malignant tumors besides pancreatic cancer before enrollment, except for non-melanoma skin cancer, carcinoma in situ of the cervix, or cured early-stage prostate cancer. * Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system diseases, cachexia, or other conditions that are intolerable to radiotherapy, chemotherapy, or surgery. * Patients with autoimmune diseases, a history of autoimmune diseases (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), as well as a history of immune deficiency, including HIV-positive test results, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation. * Patients who require systemic corticosteroid therapy (\> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days before the first administration or during the study. However, the following situations are allowed for enrollment: In the absence of active autoimmune diseases, patients are allowed to use topical or inhaled steroids, or adrenal hormone replacement therapy at a dose ≤ 10 mg/day prednisone equivalent dose. * Patients with a history of interstitial lung disease or non-infectious pneumonia. * Patients with active pulmonary tuberculosis infection detected through medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without proper treatment. * Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10\*4 copies/mL), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the analytical method).
Where this trial is running
Guangzhou, Guangdong
- Cancer center of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Miao-Zhen Qiu, MD
- Email: qiumzh@sysucc.org.cn
- Phone: 02087343351
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.