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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Retlirafusp Alfa + Apatinib + ChemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

Progression-free survival (PFS) is defined as the time from the first administration of study treatment to the date of disease progression, as assessed by the investigator, or death from any cause, whichever occurs first.

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.

Secondary outcomes

1

Overall Survival

Overall survival (OS) is defined as the time from the first administration of study treatment to death from any cause.

Time frame
Up to 3 years after the first administration of study treatment.
2

Objective response rate

Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.

Time frame
Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years
3

Duration of Response

Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death.

Time frame
Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: