Pancreatic CancerPhase 4NCT05035147
Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer
A Phase 4 study testing albumin-bound paclitaxel in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- albumin-bound paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 934 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2021to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age: ≥18 years old, no gender limit;
- Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology;
- The patient has not undergone standard systemic treatment in the past, or more than half a year after the end of postoperative treatment.For those who have undergone major surgery or radiotherapy, the interval must be more than 4 weeks and their metastases have not received any local treatment including radiotherapy, chemotherapy, surgical treatment, etc.;
- At least one measurable lesion (CT scan of tumor lesions with long diameter ≥ 10 mm, CT scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness not greater than 6 mm);
- The main organs are functioning normally, that is, they meet the following standards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14 days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALB in 14 days), TBIL <1.5 times the upper limit of normal (ULN);ALT and AST≤3ULN, accompanied by liver metastasis, then ALT and AST<5×ULN;Cr ≤1.5×ULN or creatinine clearance rate ≥60ml/min;
- The subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up
Who cannot join
- Pregnant or lactating women;
- Patients suffering from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients.
- The patient has clinically significant ascites;
- Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- Patients with active hepatitis B or C;
- Doctors think it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Rui Liu
Tianjin, Tianjin Municipality, 300000
Rui Liu, 13602139003, liurui9003@163.com
About this study
Official title: Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer
This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer
Read the detailed description
Pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.The prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.Albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. It has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.It is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.
- Conditions
- Pancreatic Cancer
- Being tested
- albumin-bound paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin-bound paclitaxelDrug
Also called gemcitabine
Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth days, with a four-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Low dose strength: albumin-bound paclitaxel + gemcitabine | Experimental | albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8 q3w Receives: Drug: albumin-bound paclitaxel |
| High dose strength: albumin-bound paclitaxel + gemcitabine | Active comparator | albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8,15 q4w Receives: Drug: albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause
Measured: through study completion, an average of 5year
Secondary outcomes (3)
Disease Control Rate(DCR)
The percentage of confirmed complete remission, partial remission and stable disease among patients with evaluable efficacy
Measured: through study completion, an average of 5year
Objective response rate(ORR)
The proportion of patients whose tumors have shrunk to a certain level and maintained for a certain period of time, including CR and PR cases.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.The subject must have measurable tumor lesions at baseline.According to the RECIST 1.1 standard, the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable (SD), and progress (PD)
Measured: through study completion, an average of 5year
Overall survival(OS)
From date of randomization until the date of death from any cause
Measured: through study completion, an average of 5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Mar 2021
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 934 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji zhi, professor, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035147
- Sponsor's protocol ID
- TJGI-003
- Status last verified
- Jul 2021
- First submitted
- 16 Aug 2021
- Last updated
- 21 Sep 2021
- 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 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05035147
- Acronym / sponsor ID
- TJGI-003
- Conditions
- Pancreatic Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 934 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Sep 2021 (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.
This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer
Detailed description
Pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.The prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.Albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. It has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.It is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose strength: albumin-bound paclitaxel + gemcitabine | Experimental | Drug: albumin-bound paclitaxelalbumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8 q3w |
| High dose strength: albumin-bound paclitaxel + gemcitabine | Active comparator | Drug: albumin-bound paclitaxelalbumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8,15 q4w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: ≥18 years old, no gender limit;
- Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology;
- The patient has not undergone standard systemic treatment in the past, or more than half a year after the end of postoperative treatment.For those who have undergone major surgery or radiotherapy, the interval must be more than 4 weeks and their metastases have not received any local treatment including radiotherapy, chemotherapy, surgical treatment, etc.;
- At least one measurable lesion (CT scan of tumor lesions with long diameter ≥ 10 mm, CT scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness not greater than 6 mm);
- The main organs are functioning normally, that is, they meet the following standards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14 days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALB in 14 days), TBIL <1.5 times the upper limit of normal (ULN);ALT and AST≤3ULN, accompanied by liver metastasis, then ALT and AST<5×ULN;Cr ≤1.5×ULN or creatinine clearance rate ≥60ml/min;
Key exclusion criteria (7 listed)
- Pregnant or lactating women;
- Patients suffering from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients.
- The patient has clinically significant ascites;
- Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
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 paclitaxelAlso: gemcitabineExperimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth days, with a four-week cycle | Drug | High dose strength: albumin-bound paclitaxel + gemcitabine, Low dose strength: albumin-bound paclitaxel + gemcitabine |
Primary outcome
Progression-free Survival (PFS)
Time frame: through study completion, an average of 5year
From date of randomization until the date of first documented progression or date of death from any cause
3 secondary outcomes
Disease Control Rate(DCR)
Time frame: through study completion, an average of 5year
Objective response rate(ORR)
Time frame: through study completion, an average of 5year
Overall survival(OS)
Time frame: through study completion, an average of 5year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
Ji zhi, professor study director
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing albumin-bound paclitaxel in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu rui, professor (13602139003, Liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: through study completion, an average of 5year). 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 21 Sep 2021.