Clinical trial · Interventional

AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer

A Prospective, Single-Arm Study of Nab-paclitaxel/Gemcitabine Combined With Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer

NCT06938503CI-TRIAL-00088774not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of nab-paclitaxel/gemcitabine combined with nimotuzumab sequential irreversible electroporation ablation for locally advanced pancreatic cancer. The main endpoint is overall survival (OS).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreatic Cancer, Adult	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.85

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
AG regimen	Drug	—	UNRESOLVED
Nimotuzumab	Drug	Nimotuzumab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
AG+Nimotuzumab
interventionNames
1. Drug: AG regimen
2. Drug: Nimotuzumab

Primary outcomes (1)

measure
overall survival (OS)
timeFrame
Up to 24 months
description
OS, defined as the time from the beginning of treatment to death due to any cause.

Secondary outcomes (3)

measure
progression-free survival (PFS)
timeFrame
Up to 24 months
description
PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

* 1\. Age 18-75 years old, gender unlimited;
* 2\. Histologically or cytologically confirmed pancreatic cancer;
* 3\. Confirmed as locally advanced pancreatic cancer by CT/MRI imaging, with no evidence of distant metastasis;
* 4\. No prior chemotherapy or other tumor systemic therapy;
* 5\. Measurable disease according to RECIST criteria v1.1;
* 6\. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
* 7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
* 8\. Life expectancy is expected to be ≥3 months;
* 9\. Fertile subjects are willing to take contraceptive measures during the study period.
* 10\. Good compliance and signed informed consent voluntarily.

Exclusion Criteria:

* 1\. Refuse chemotherapy or surgery;
* 2\. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
* 3\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* 4\. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
* 5\. Undergone major surgery within 30 days;
* 6\. Participated in other drug related clinical trials within 4 weeks;
* 7\. Known allergy to prescription or any component of the prescription used in this study;
* 8\. With HIV, or active hepatitis (hepatitis B, hepatitis C);
* 9\. Failure to recover from treatment-related toxicity to ≤ grade 1 (adverse events such as alopecia judged by the researcher not to affect the treatment with the research drug are excluded);
* 10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

References

Publications (0)

Data not yet available

No reference posted for this study.