Patients With High-grade Pancreatic Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-23

Study Completion Date

2029-12-31

Brief Summary

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* Pancreatic neuroendocrine tumor (pNET) is a rare form of cancer. Treatment options such as hormonal therapy (octreotide) and targeted therapy (everolimus and sunitinib) may be considered for grade 1 or 2 pNETs; however, cytotoxic chemotherapy is essential in cases with grade 3 pNETs or pNECs.
* Cisplatin/etoposide remains the treatment of choice for high-grade pNET/pNEC. Other irinotecan-based therapies, such as FOLFIRI (cisplatin/irinotecan), FOLFOX, and temozolomide ± capecitabine, have been employed; however, a standard of care remains to be established.

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Detailed Description

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* Lurbinectedin, a selective inhibitor of oncogenic transcription, recently received accelerated FDA approval for lung cancer (small cell type) after demonstrating efficacy in an open-label, phase II basket study (ORR 35%, mOS 9.3 months, mPFS 3.5 months).
* A previous study that involved patients with grade 2 or higher NET/NEC who had undergone treatment with lurbinectedin revealed that the ORR, mOS, and mPFS of the six patients with pNET was 6.5%, 7.4 months, and 1.4 months, respectively.

Conditions

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Neuroendocrine Tumor of Pancreas Pancreatic Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.

Group Type EXPERIMENTAL

Lurbinectedin 4 MG Injection [Zepzelca]

Intervention Type DRUG

Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.

Interventions

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Lurbinectedin 4 MG Injection [Zepzelca]

Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Pancreatic neuroendocrine tumor or neuroendocrine carcinoma
* Documented failure of prior standard anti-cancer treatment
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
* Platelet count ≥ 100,000 cells/mm³
* Ability to understand study content, willingness to comply with study procedures, and commitment to complete the study

Exclusion Criteria

* Currently receiving treatment for other cancers (except those who completed treatment and have been disease-free for at least 2 years prior to enrollment)
* Pregnant or breastfeeding women
* Deemed unsuitable for participation by the investigator due to clinical or medical reasons

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No