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.
There is no standard treatment for patients with metastatic pancreatic cancer who failed to FOLFIRINOX or AG (consisting of Gemcitabine and Abraxane). Patients with metastatic pancreatic cancer who are unable to tolerate or have failed to respond to standard chemotherapy will be enrolled in this clinical trial. They will be administered a combination treatment of Sapropterin Dihydrochloride and PD-1 antibody. The primary endpoints of this study are objective response rate and safety. The secondary endpoints will encompass overall survival, progression-free survival, and quality of life. The study aims to enroll a total of 20 participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sapropterin Dihydrochloride: 20mg/kg, qd
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGObjective response rate
The percentage of patients whose cancer shrinks or disappears after treatment
Time frame: 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
Time frame: Every 3 weeks from first treatment to disease progression or totally 2 years Based on irRECIST
Overall Survival (OS)
The time from registration to death due to any cause, or censored at date last known alive.
Time frame: up to approximately 2 year
Progression-Free Survival (PFS)
PFS as measured in accordance with the irRECIST version 1.1
Time frame: up to approximately 1 year
EORTC QLQ-C30 survey
Quality of life survey
Time frame: up to approximately 2 year
EORTC-QLQ-PAN26 survey
Quality of life survey
Time frame: up to approximately 2 year
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