Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer
ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital
About this trial
This is a prospective, open-label, single-arm clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with apatinib and chemotherapy as second-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer who have experienced disease progression after first-line systemic therapy. Approximately 37 participants will be enrolled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety.
Eligibility criteria
Qualifiers
Age 18 to 75 years, male or female.
Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic cancer.
ECOG Performance Status of 0 or 1.
Disease progression after first-line systemic therapy.
Disqualifiers
Known hypersensitivity to the investigational drug or any of its excipients.
Major surgery, open biopsy, or significant traumatic injury within 4 weeks before study treatment.
Participation in another investigational drug clinical study within 4 weeks before enrollment.
History of other malignancy within the past 5 years, except for malignancies that have been definitively treated and are considered cured.
Trial design
Treatments tested in this trial
- Retlirafusp Alfa
- Apatinib
- Fluoropyrimidine-Based Chemotherapy
Treatment groups
37 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov