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Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

This is a single-arm, prospective, multicenter, open-label clinical trial, which aims to observe and evaluate the efficacy and safety of Relafen-α combined with famitinib and AG chemotherapy as first-line therapy in patients with unresectable pancreatic cancer.

The study enrolls patients with unresectable locally advanced and metastatic pancreatic cancer.

Progression-free survival (PFS) is set as the primary efficacy endpoint. Approximately 88 patients with unresectable locally advanced and metastatic pancreatic cancer will be recruited. After adequate informed consent and signature of the informed consent form, eligible screened subjects will receive Relafen-α in combination with famitinib plus nab-paclitaxel/gemcitabine.

Treatment regimen： Relafen-α (1800 mg, q3w, Cycle 1); Famitinib (15 mg, qd, q3w); nab-paclitaxel (125 mg/m², d1, d8, Q3W, for 6 cycles) combined with gemcitabine (1000 mg/m², d1, d8, Q3W, for 6 cycles). Treatment will be continued until disease progression or intolerable toxicity, whichever occurs first.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 80 years, of any gender;

Histopathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma;

Unresectable disease or distant metastasis confirmed by imaging evidence. Unresectable pancreatic ductal adenocarcinoma is defined as patients with distant metastasis, or a subset of locally advanced pancreatic cancer (LAPC) with invasion of surrounding major blood vessels that cannot be resected and reconstructed;

Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;

Disqualifiers

Subjects with hypersensitivity to Retlirafusp alfa, famitinib, gemcitabine, albumin-bound paclitaxel or their excipients;

Histopathologically-confirmed other pancreatic malignancies, such as pancreatic acinar cell carcinoma, pancreatic neuroendocrine tumor;

Moderate-to-large pleural effusion, pericardial effusion or ascites with clinical symptoms, which requires frequent drainage (≥ 1 time per week) as judged by the investigator;

History of organ transplantation (including autologous bone-marrow transplantation and peripheral stem-cell transplantation);

Trial design

Design model

Single group

Treatments tested in this trial

  • Retlirafusp alfa Injection

    Drug

    etlirafusp alfa (1800 mg, q3w, Cycle 1)，until the disease or toxicity becomes intolerable (whichever comes first)

  • Famitinib

    Drug

    Famitinib (15mg, once daily, every 3 weeks),until the disease or toxicity becomes intolerable (whichever comes first).

  • AG

    Drug

    Albumin-bound paclitaxel (125mg/m² on days 1 and 8, every 3 weeks, for 6 cycles) combined with gemcitabine (1000mg/m² on days 1 and 8, every 3 weeks, for 6 cycles) until the disease progresses or toxicity becomes unbearable (whichever happens first).

Treatment groups

88 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival

Time frame
From date of informed consent until date of first documented progression or death, assessed every 2 cycles (approximately 6 weeks) up to 2 years

Secondary outcomes

1

Objective Response Rate

Time frame
From date of study entry up to 24 months.
2

Disease Control Rate

Time frame
From date of study entry up to 24 months.
3

Overall Survival

Time frame
From date of study entry (signing of informed consent) until death from any cause, assessed up to 24 months after the last patient enrolled.
4

AE

Time frame
From signing of informed consent until 90 days after the last dose of study treatment.

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital of Zhengzhou University

Lead sponsor

Source ClinicalTrials.gov

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