PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

NCT06396637 | Recruiting Phase 2

• 1 other identifier: SYSUCC-PDAC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The prognosis for pancreatic cancer remains dismal, with current guidelines favoring FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane) as the primary chemotherapeutic option. However, research has indicated limited benefits for patients with pancreatic cancer undergoing immunotherapy using Anti-PD-1 antibodies. In this context, researchers aim to investigate the therapeutic potential of Sapropterin Dihydrochloride combined with PD-1 antibody in patients with metastatic pancreatic cancer who failed to standard treatment.

Conditions

Pancreatic Adenocarcinoma Metastatic

Keywords

Pancreatic adenocarcinoma; PD-1 inhibitor

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  The percentage of patients whose cancer shrinks or disappears after treatment

  Every 6 weeks (2 cycles) from first treatment to disease progression or totally 2 years Based on irRECIST

• Adverse events by NCI-CTCAE v5.0

  Safety and tolerability

  Every 3 weeks from first treatment to disease progression or totally 2 years Based on irRECIST

Secondary Outcomes (4)

• Overall Survival (OS)

  up to approximately 2 year

• Progression-Free Survival (PFS)

  up to approximately 1 year

• EORTC QLQ-C30 survey

  up to approximately 2 year

• EORTC-QLQ-PAN26 survey

  up to approximately 2 year

Study Arms (1)

Treatment arm

EXPERIMENTAL

PD-1 Antibody combined with Sapropterin Dihydrochloride

Drug: Sapropterin Dihydrochloride

Interventions

Sapropterin Dihydrochloride DRUG

Sapropterin Dihydrochloride: 20mg/kg, qd

Also known as: PD-1 Antibody

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

sapropterin; spartalizumab

Central Study Contacts

Miao-Zhen Qiu, MD

CONTACT

02087343351; qiumzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: PD-1 Antibody combined with Sapropterin Dihydrochloride

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)