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Advanced Pancreatic CancerPhase 3NCT06492941

A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer

A Phase 3 study testing Docetaxel for Injection (Albumin bound) in people with Advanced Pancreatic Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Docetaxel for Injection (Albumin bound)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
No sites listed yet
Study dates
12 Aug 2024to 21 Nov 2026
Phase
Phase 3
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

  • 1. Patients aged ≥18 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.
  • 2. Histologically or cytologically confirmed diagnosis of pancreatic cancer (including adenosquamous carcinoma).
  • 3. Patients who have got disease progression or toxic intolerance after previous standard treatment (gemcitabine based and fluorouracil based therapy).
  • 4. At least one evaluable lesion according to RECIST 1.1 .
  • 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • 6. Patients with fine organ function (no medical supportive treatments such as blood component transfusion, growth factors within 2 weeks before taking the relevant inspections):
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  • ANC≥1.5×10^9/L；
  • Hb≥90 g/L；
  • PLT≥100×10^9/L；
  • ALB≥30 g/L；
  • CR≤1.5× ULN and creatinine clearance≥40 mL/min（Cockcroft-Gault）；
  • Total bilirubin≤1.5 × ULN(≤ 2 × ULN for patients with obstructive jaundice, ≤3 × ULN for patients with Gilbert's syndrome)；
  • ALT and AST ≤ 3× ULN (≤5× ULN for patients with liver metastasis)；
  • ALP≤2.5× ULN；
  • PT、INR≤1.5×ULN。
  • 7. The patient must agree to take adequate contraception from signing of ICF through 6 months after last dose, women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug.

Who cannot join

  • 1. Patients who have a history of severe allergy to any excipients of the investigational drug or taxanes，or known allergy and/or contraindications to glucocorticoids (including but not limited to active digestive tract ulcers, severe hypertension, severe hypokalemia, glaucoma, etc.).
  • 2. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment.
  • 3. Previous history of inflammatory bowel disease, chronic diarrhea, and gastrointestinal bleeding.
  • 4. Patients who had a history of other active malignant tumors within 2 years before the first dose of the investigational drug, except for the study disease pancreatic cancer and curable cancer that had been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ that had been excised).
  • 5. Patients with active hepatitis B (HBsAg and/or HBcAb positive but HBV DNA < 2000 IU/mL can be included), active hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive.
  • 6. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for alopecia, hyperpigmentation, or other toxicity without safety risk judged by the investigator).
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  • 7. Patients with a history of severe cardiovascular disease, including but not limited to:：
  • Severe heart rhythm or conduction abnormalities, including but not limited to ventricular arrhythmia requiring clinical intervention and third degree atrioventricular block within 6 months before the first dose of the investigational drug；
  • History of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery within 6 months before the first dose of the investigational drug;；
  • Heart failure with New York Heart Association (NYHA) Classification of Class Ш and above；
  • Long QTc syndrome or QTc > 480 msec；
  • Poorly controlled hypertension (Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening period).
  • 8. Patients with uncontrolled serous cavity effusion requiring frequent drainage or medical intervention (e.g., pleural effusion, abdominal effusion, pericardial effusion, etc., additional intervention was needed within 2 weeks after intervention, excluding exfoliative cytology testing of the exudate) within 2 weeks before the first dose of the investigational drug.
  • 9. Patients with severe or active infections (including tuberculous infections) that require systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of the investigational drug, antiviral therapy for patients with viral hepatitis is permitted.
  • 10. Received any anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) and any clinical trial intervention within 4 weeks prior to the first use of the investigational drug or within 5 half-lives of the most recently used anti-tumor drug (whichever is shorter), and used traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 14 days before the first use of the investigational drug.
  • 11. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.
  • 12. Patients who have undergone major surgery within 4 weeks before the first dose of the investigational drug and had not recovered sufficiently, or who need to undergo major surgery during the study.
  • 13. Pregnant or nursing women.
  • 14. Patients who is participating in another clinical study simultaneously unless it is an observational (non-interventional) clinical study or within the follow-up period of an interventional study.
  • 15. Other situations that the investigator considers not suitable for participating in the clinical study, including but not limited to: the patient is complicated by severe or uncontrolled medical conditions, which will increase the safety risk, interfere with the interpretation of study results or affect the study compliance.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Randomized, Double-blind, Multicenter Phase Ⅲ Clinical Study of Docetaxel for Injection (Albumin Bound) Combined With Best Supportive Care Versus Placebo Plus Best Supportive Care in Advanced Pancreatic Cancer

This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin Bound) in combination with best supportive care versus placebo in combination with best supportive care in participants with pancreatic cancer who have received gemcitabine-containing and fluorouracil-containing regimens.

Read the detailed description

This study is a randomized, double-blind, multicenter, phase Ⅲ clinical study to compare the clinical efficacy and safety of Docetaxel for Injection (Albumin bound) plus best supportive care versus placebo plus best supportive care in participants with pancreatic cancer who have received a previous treatment regimen containing gemcitabine and fluorouracil. It is planned to enroll 142 participants, and participants will be randomized to receive Docetaxel for Injection (albumin bound) in combination with best supportive care or placebo in combination with best supportive care in a 2:1 ratio. Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care.

Being tested
Docetaxel for Injection (Albumin bound), Placebo, Best supportive care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel for Injection (Albumin bound)Drug

    Docetaxel for Injection (Albumin bound), by intravenous infusion, every 3 weeks.

  • PlaceboDrug

    Placebo was human blood albumin without the active ingredient docetaxel

  • Best supportive careDrug

    Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care.

Study groups in NCT06492941
Study groupRoleWhat they receive
Docetaxel for Injection (Albumin Bound) in combination with best supportive careExperimentalDocetaxel for Injection (Albumin Bound) ：i.v., q3w,100mg/m^2； Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care
Receives: Drug: Docetaxel for Injection (Albumin bound); Drug: Best supportive care
Placebo in combination with best supportive carePlacebo comparatorPlacebo ：i.v., q3w； Best supportive care includes, but is not limited to, pain control, nutritional support, and psychological care
Receives: Drug: Placebo; Drug: Best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

    The overall survival (OS) of the two groups. All the participants received tumor assessment every 6 weeks according to RECIST1.1.

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  1. PFS

    All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the progression-free survival (PFS) .

    Measured: Up to approximately 2 years

  2. ORR

    All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the objective response rate (ORR).

    Measured: Up to approximately 2 years

  3. DCR

    All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the disease control rate (DCR).

    Measured: Up to approximately 2 years

  4. DOR

    All the participants received tumor assessment every 6 weeks according to RECIST1.1 to evaluate the duration of response (DOR).

    Measured: Up to approximately 2 years

  5. Incidence of AE and SAE

    Incidence of AE and SAE

    Measured: Up to approximately 2 years

  6. PK

    Plasma concentration of docetaxel (free and total)

    Measured: At the end of Cycle 1(each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start12 Aug 2024 (estimated)
  3. Primary completion14 Apr 2026 (estimated)
  4. Study completion21 Nov 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 2:1 ratio to Docetaxel for Injection (Albumin Bound ) in combination with best supportive care or placebo in combination with best supportive care
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492941
Sponsor's protocol ID
HB1801-011
Status last verified
Jul 2024
First submitted
24 Jun 2024
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel for Injection (Albumin bound) in people with Advanced Pancreatic Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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 16 inclusion and 20 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: opening soon, as of the sponsor's last update on 9 Jul 2024. 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. Some participants in this study may receive a placebo. 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 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?

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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492941.

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 9 Jul 2024.

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