Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer

Sponsor
Tang-Du Hospital
Study ID
NCT07773363
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Retlirafusp Alfa — DRUG
    Retlirafusp alfa will be administered in combination with apatinib and fluoropyrimidine-based chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer.
  • Apatinib — DRUG
    Apatinib will be administered in combination with retlirafusp alfa and fluoropyrimidine-based chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer.
  • Fluoropyrimidine-Based Chemotherapy — DRUG
    Fluoropyrimidine-based chemotherapy selected at the investigator's discretion will be administered in combination with retlirafusp alfa and apatinib as second-line treatment for locally advanced or metastatic pancreatic cancer.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Aug 30, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Retlirafusp Alfa + Apatinib + Chemotherapy
    Participants will receive retlirafusp alfa combined with apatinib and fluoropyrimidine-based chemotherapy selected at the investigator's discretion as second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or other criteria for treatment discontinuation are met.

Primary Outcome Measure

Progression-free survival [ Time Frame: Progression-free survival (PFS) will be assessed by the investigator according to RECIST 1.1, for up to 2 years after the first administration of study treatment. ]

Central Contacts

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