Advanced Hepatobiliary and Malignant TumorsPhase 2/3NCT04060472
Paclitaxel (Albumin-bound) and Oxaliplatin for Advanced Hepatobiliary and Malignant Tumors
A Phase 2/3 study testing albumin-bound paclitaxel + oxaliplatin in people with Advanced Hepatobiliary and Malignant Tumors, run by Dong Wang.
Trial summary
1. Advantages of albumin-bound paclitaxel Paclitaxel for injection (albumin-binding type) uses human serum albumin (HAS) as a carrier, and paclitaxel and HSA are made into paclitaxel-bound albumin nanoparticles by a high-pressure homogenization technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatobiliary and Malignant Tumors
- What is being tested?
- albumin-bound paclitaxel + oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2019to 20 Oct 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients are ≥ 18 years old; 2) Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination; 3) Having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria; 4) Estimated survival time > 3 months; 5) There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history; 6) ECOG PS score ≤ 2 points; 7) Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%; 8) Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment; 9) Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min; 10) Patients can understand and sign the informed consent form.
Who cannot join
- 1) Pregnant or lactating female patients (women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose, if they are positive, ultrasound examination is required to be performed to exclude pregnancy); women of childbearing age refuse to receive contraception.
- 2) Having other malignant tumors, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ carcinoma in any other regions; 3) Having abnormal bone marrow hyperplasia and other hematopoietic disorders; 4) Having active infections, HIV infection, and viral hepatitis that require systemic treatment; 5) Child-Pugh score > 7 points; 6) Being combined with medium-large ascites or hepatic encephalopathy; 7) Subjects with ≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0; 8)Patients with severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs intervention; 9) Being allergic to the drug or drug ingredients used in this test or having hypersensitivity history; 10) Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 11) Having dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 12) Being considered to be unsuitable for enrollment by investigators.
About this study
Official title: Single-center, Single-arm and Phase II/III Clinical Study of Paclitaxel (Albumin-binding) Combined With Oxaliplatin as First-line Treatment for Advanced Hepatobiliary and Malignant Tumors
- Advantages of albumin-bound paclitaxel Paclitaxel for injection (albumin-binding type) uses human serum albumin (HAS) as a carrier, and paclitaxel and HSA are made into paclitaxel-bound albumin nanoparticles by a high-pressure homogenization technique. After injection of paclitaxel (albumin-binding) into the blood, it rapidly disintegrates and disperses into a smaller albumin-paclitaxel complex, which binds and activates the gp60 albumin receptor on vascular endothelial cells, interacts with Caveolin on the cell membrane, and then is transported to the tumor intercellular substance by transcytosis. Tumor cells can secrete a SPARC protein with a specific affinity for albumin, which actively captures the albumin-paclitaxel complex in the tumor stroma and accumulates around the tumor cells. Since tumor neovascular endothelial cells highly express gp60 receptor and the SPARC protein is also highly expressed in the tumor region, the special transport mechanism of "gp60- Caveolin / caveola -SPARC protein" makes the paclitaxel for injection (albumin binding) have unique targeting and penetrating properties toward tumor tissues, hence the drug is highly concentrated in the tumor tissue, which can better increase the therapeutic effect and reduce the damage to normal tissues.
Paclitaxel for injection (albumin-binding type) has the following advantages: (1) it is unnecessary to pre-administer anti-allergic drugs, the infusion time is within 30 min, and patients have good compliance; (2) due to its higher safety, the dosage can be given as high as 260-300 mg/m2; (3) it makes full use of gp60 / cysteine acid secretory protein (SPARC protein) channel to make the drug enrich toward the tumor area, and the effect is good; (4) as the dosage is within 80 ~ 300 mg/m2, the AUC increase proportionally with the administered dose, ]the body is linearly metabolized., the half-life period does not prolong with the dose, and the clinical medication is safe and controllable. Currently, the drug has been approved for breast cancer treatment in China; approved by the US Food and Drug Administration (FDA) for breast cancer, lung cancer, and pancreatic cancer treatment; approved for gastric cancer treatment in Japan; and NCCN guidelines recommend it for the treatment of intrahepatic cholangiocarcinoma, melanoma, ovarian cancer, and cervical cancer.
Read more
In summary, based on the biological advantages of albumin-binding paclitaxel such as high-distribution, high-dose, high-efficiency, and low-toxicity, the reported good clinical benefit and safety for hepatobiliary and malignant tumors, and the limited data about albumin-bound paclitaxel + oxaliplatin as the first-line treatment for advanced hepatobiliary and pancreatic malignancies, especially in Chinese patients, our center believes that is feasible and necessary to explore the effectiveness and safety of paclitaxel for injection (albumin-binding) combined with oxaliplatin as the first-line drugs for treatment of advanced oxaliplatin-based malignant tumors.
2 Purposes To evaluate the efficacy and safety of paclitaxel (albumin-bound) combined with oxaliplatin as the first-line drugs for treatment of advanced hepatobiliary and malignant tumors.
Primary endpoint: progression-free survival (PFS) Secondary study endpoints: disease control rate (DCR), overall survival (OS), and incidence and severity of adverse events (AE).
3 Research plan 3.1 Research Design This study was a single-center, one-arm, phase II/III clinical trial, which plans to recruit 57 patients.
- Being tested
- albumin-bound paclitaxel + oxaliplatin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin-bound paclitaxel + oxaliplatinDrug
Using albumin-bound paclitaxel (125 mg/m2, d1, 8, 15, ivgtt) + oxaliplatin (80 mg/m2, d1, 8, ivgtt) with or without other chemotherapeutic drugs, 28 days /cycle, until the disease progresses or patients can not tolerate toxicity. The investigators decide the follow-up treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| albumin-bound paclitaxel + oxaliplatin | Experimental | Not described Receives: Drug: albumin-bound paclitaxel + oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free surviva
Measured: 2 years
Secondary outcomes (3)
DCR
Disease control rate
Measured: 2 years
OS
overall survival
Measured: 2 years
AE
incidence and severity of adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start20 Aug 2019 (estimated)
- Primary completion20 Apr 2021 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatobiliary and Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Wang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060472
- Sponsor's protocol ID
- ThirdMMUb
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Single-arm and Phase II/III Clinical Study of Paclitaxel (Albumin-binding) Combined With Oxaliplatin as First-line Treatment for Advanced Hepatobiliary and Malignant Tumors
- ClinicalTrials.gov ID
- NCT04060472
- Acronym / sponsor ID
- ThirdMMUb
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Dong WangUniversity, hospital or other
- Study start
- 20 Aug 2019 (estimated)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Advantages of albumin-bound paclitaxel Paclitaxel for injection (albumin-binding type) uses human serum albumin (HAS) as a carrier, and paclitaxel and HSA are made into paclitaxel-bound albumin nanoparticles by a high-pressure homogenization technique. After injection of paclitaxel (albumin-binding) into the blood, it rapidly disintegrates and disperses into a smaller albumin-paclitaxel complex, which binds and activates the gp60 albumin receptor on vascular endothelial cells, interacts with Caveolin on the cell membrane, and then is transported to the tumor intercellular substance by transcytosis. Tumor cells can secrete a SPARC protein with a specific affinity for albumin, which actively captures the albumin-paclitaxel complex in the tumor stroma and accumulates around the tumor cells. Since tumor neovascular endothelial cells highly express gp60 receptor and the SPARC protein is also highly expressed in the tumor region, the special transport mechanism of "gp60- Caveolin / caveola -SPARC protein" makes the paclitaxel for injection (albumin binding) have unique targeting and penetrating properties toward tumor tissues, hence the drug is highly concentrated in the tumor tissue, which can better increase the therapeutic effect and reduce the damage to normal tissues.
Paclitaxel for injection (albumin-binding type) has the following advantages: (1) it is unnecessary to pre-administer anti-allergic drugs, the infusion time is within 30 min, and patients have good compliance; (2) due to its higher safety, the dosage can be given as high as 260-300 mg/m2; (3) it makes full use of gp60 / cysteine acid secretory protein (SPARC protein) channel to make the drug enrich toward the tumor area, and the effect is good; (4) as the dosage is within 80 ~ 300 mg/m2, the AUC increase proportionally with the administered dose, ]the body is linearly metabolized., the half-life period does not prolong with the dose, and the clinical medication is safe and controllable. Currently, the drug has been approved for breast cancer treatment in China; approved by the US Food and Drug Administration (FDA) for breast cancer, lung cancer, and pancreatic cancer treatment; approved for gastric cancer treatment in Japan; and NCCN guidelines recommend it for the treatment of intrahepatic cholangiocarcinoma, melanoma, ovarian cancer, and cervical cancer.
In summary, based on the biological advantages of albumin-binding paclitaxel such as high-distribution, high-dose, high-efficiency, and low-toxicity, the reported good clinical benefit and safety for hepatobiliary and malignant tumors, and the limited data about albumin-bound paclitaxel + oxaliplatin as the first-line treatment for advanced hepatobiliary and pancreatic malignancies, especially in Chinese patients, our center believes that is feasible and necessary to explore the effectiveness and safety of paclitaxel for injection (albumin-binding) combined with oxaliplatin as the first-line drugs for treatment of advanced oxaliplatin-based malignant tumors.
2 Purposes To evaluate the efficacy and safety of paclitaxel (albumin-bound) combined with oxaliplatin as the first-line drugs for treatment of advanced hepatobiliary and malignant tumors.
Primary endpoint: progression-free survival (PFS) Secondary study endpoints: disease control rate (DCR), overall survival (OS), and incidence and severity of adverse events (AE).
3 Research plan 3.1 Research Design This study was a single-center, one-arm, phase II/III clinical trial, which plans to recruit 57 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| albumin-bound paclitaxel + oxaliplatin | Experimental | Drug: albumin-bound paclitaxel + oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients are ≥ 18 years old; 2) Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination; 3) Having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria; 4) Estimated survival time > 3 months; 5) There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history; 6) ECOG PS score ≤ 2 points; 7) Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%; 8) Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment; 9) Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min; 10) Patients can understand and sign the informed consent form.
Key exclusion criteria (2 listed)
- 1) Pregnant or lactating female patients (women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose, if they are positive, ultrasound examination is required to be performed to exclude pregnancy); women of childbearing age refuse to receive contraception.
- 2) Having other malignant tumors, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ carcinoma in any other regions; 3) Having abnormal bone marrow hyperplasia and other hematopoietic disorders; 4) Having active infections, HIV infection, and viral hepatitis that require systemic treatment; 5) Child-Pugh score > 7 points; 6) Being combined with medium-large ascites or hepatic encephalopathy; 7) Subjects with ≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0; 8)Patients with severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs intervention; 9) Being allergic to the drug or drug ingredients used in this test or having hypersensitivity history; 10) Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 11) Having dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 12) Being considered to be unsuitable for enrollment by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albumin-bound paclitaxel + oxaliplatinUsing albumin-bound paclitaxel (125 mg/m2, d1, 8, 15, ivgtt) + oxaliplatin (80 mg/m2, d1, 8, ivgtt) with or without other chemotherapeutic drugs, 28 days /cycle, until the disease progresses or patients can not tolerate toxicity. The investigators decide the follow-up treatment plan. | Drug | albumin-bound paclitaxel + oxaliplatin |
Primary outcome
PFS
Time frame: 2 years
Progression-free surviva
3 secondary outcomes
DCR
Time frame: 2 years
OS
Time frame: 2 years
AE
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing albumin-bound paclitaxel + oxaliplatin in people with Advanced Hepatobiliary and Malignant Tumors, run by Dong Wang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.