Trial Title:
A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors
NCT ID:
NCT06632574
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All participants receive the same treatment, and there is no comparison group.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
paclitaxel cationic liposomes
Description:
Paclitaxel cationic liposomes is a modified new drug. In this study, administration is
performed through arterial catheter infusion.
Arm group label:
Experimental arm
Summary:
This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase
I clinical study in patients with advanced solid tumors.
Detailed description:
This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase
I clinical study in patients with advanced solid tumors.
The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and
preliminary efficacy of paclitaxel cationic liposomes for injection administered via
transcatheter arterial infusion in the treatment of advanced solid tumors.
Paclitaxel cationic liposomes will be administered via arterial infusion on the first day
of each cycle, with each treatment cycle lasting 3 weeks. Eligible participants will
receive 4-6 cycles of study treatment. Treatment may be terminated early in the event of
the following: disease progression, intolerable toxicity, initiation of new anti-tumor
therapy, withdrawal of informed consent, loss to follow-up, death, or any other
circumstances meeting the criteria for treatment discontinuation (whichever occurs
first).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age ≥ 18 years.
-
2. Histologically or cytologically diagnosed advanced solid tumors suitable for
arterial infusion chemotherapy, including but not limited to the following
types:
- Gastrointestinal tumors (e.g., gastric cancer, liver cancer,
cholangiocarcinoma, pancreatic cancer, colorectal cancer, etc.);
- Gynecological tumors (e.g., ovarian cancer, endometrial cancer, etc.);
- Non-small cell lung cancer (NSCLC);
- Liver metastases.
-
3. According to RECIST 1.1, at least one measurable lesion in the arterial
infusion area.
-
4. If life-threatening primary lesions are within the arterial infusion area,
limited lesions outside the arterial infusion area at baseline are acceptable.
-
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
-
6. Life expectancy of at least 3 months.
-
7. Adequate organ function, with laboratory tests meeting the following criteria
(no blood transfusion or hematopoietic growth factors within 14 days):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^2/L.
- Platelets (PLT) ≥ 100 × 10^9/L.
- Hemoglobin (Hb) ≥ 90 g/L.
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for individuals
with liver metastasis or liver cancer, TBIL ≤ 2 × ULN.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 × ULN;
for liver metastasis or liver cancer, ALT, AST ≤ 5 × ULN.
- Creatinine clearance (Ccr) > 50 mL/min (calculated using the Cockcroft-Gault
formula).
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; international
normalized ratio (INR) ≤ 1.5 × ULN.
-
8. Fertile individuals (male and female) must agree to use reliable contraceptive
methods (hormonal contraceptives, barrier methods, or abstinence) with their
partners during the trial and for at least 6 months after the last dose of
study medication. Women of childbearing potential must have a negative
pregnancy test within 7 days prior to enrollment.
-
9. Fully understand the clinical trial and voluntarily sign a written informed
consent form.
Exclusion Criteria:
-
1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy,
targeted therapy, immunotherapy, or participated in another clinical trial
within 4 weeks prior to the first administration of the study drug, or within 4
weeks or 5 half-lives of the treatment drug (whichever is shorter).
-
2. Known symptomatic central nervous system or meningeal metastases, or other
evidence of uncontrolled central nervous system or meningeal metastases, deemed
unsuitable for enrollment by the investigator.
-
3. Unresolved adverse reactions from previous anti-tumor treatments not yet
recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities
deemed non-risky by the investigator).
-
4. Concurrent participation in another clinical trial, unless it is observational
(non-interventional) or in the follow-up period of an interventional trial.
-
5. Major surgery or invasive intervention within 28 days prior to the first dose.
-
6. Use of any anti-cancer herbal or traditional Chinese medicine approved by the
National Medical Products Administration (NMPA) within 14 days prior to the
first dose.
-
7. Known severe allergic reactions to the study drug or its components/excipients.
-
8. Active bacterial, fungal, or viral infections requiring intravenous antibiotic,
antifungal, or antiviral treatment prior to the first dose. Participants
receiving prophylactic infection treatment with no signs of active infection
may be considered for enrollment.
-
9. History of immunodeficiency diseases, including positive HIV antibodies.
-
10. Hepatitis B surface antigen (HBsAg) positive with HBV DNA above the measurable
limit or 1000 copies/mL (500 IU/mL) (whichever is lower), or HCV antibody
positive with HCV RNA above the measurable limit or 1000 copies/mL (whichever
is lower). Individuals whose levels are reduced to below the standard following
antiviral treatment may be screened.
-
11. Underlying medical conditions (including laboratory abnormalities), alcohol or
drug abuse, or dependence that may impair the administration of study drugs or
interpretation of drug toxicity and adverse events (AEs), or lead to
insufficient or reduced trial compliance.
-
12. Severe cardiovascular disease history, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities requiring clinical
intervention, such as ventricular arrhythmias or grade II-III atrioventricular
block;
- Average QTcF > 450 ms from three resting 12-lead ECGs;
- Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or
higher cardiovascular events within 6 months prior to the first dose;
- New York Heart Association (NYHA) class II or higher, or left ventricular
ejection fraction (LVEF) < 50%;
- Any factors increasing the risk of QTc prolongation or arrhythmias, such as
heart failure, hypokalemia, congenital long QT syndrome, family history of long
QT syndrome or unexplained sudden death in a first-degree relative under 40
years old, or concurrent use of QT-prolonging drugs.
- Uncontrolled hypertension (screening systolic BP ≥ 160 mmHg and/or diastolic BP
≥ 100 mmHg).
- 13.History of other malignancies within the past 3 years or concurrent active
malignancies (localized, curable malignancies such as basal cell carcinoma of the
skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ
prostate cancer, cervical carcinoma in situ, and in situ breast cancer may be
included).
-
14. Patients with ultrasound-detected limb vascular thrombosis with potentially
serious consequences during screening, or participants with thromboembolic
events within 3 months prior to enrollment.
-
15. Individuals with coagulopathy or a history of severe bleeding, or who
experienced major bleeding events such as intracranial hemorrhage,
gastrointestinal bleeding, or purpura within the last 3 months.
-
16. Pregnant or breastfeeding women.
-
17. Any other reasons deemed by the investigator to make the individual unsuitable
for participation in the clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongda Hospital, Southeast University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Start date:
March 19, 2014
Completion date:
March 31, 2027
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06632574
