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Gastric CancerPhase 3NCT06296706

A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer

A Phase 3 study testing Docetaxel for injection (Albumin-bound) and Taxotere (docetaxel) in people with Gastric Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Docetaxel for injection (Albumin-bound) and Taxotere (docetaxel)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
1 siteChina
Study dates
27 Feb 2024to 1 Jun 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age: 18-75 years (inclusive) (Whichever is on the day of signing the informed consent form).
  • 2. Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
  • 3. Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction that has progressed after receiving first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
  • 4. Evidence of disease progression on imaging during or after the last systemic treatment as confirmed by investigator.
  • 5. At least one assessable lesion according to RECIST V1.1; the area should not have received previous radiotherapy, or there should be evidence of definite progress of the lesion after completion of radiotherapy.
  • 6. Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
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  • 7. Adequate main organ function.
  • 8. Eastern Cooperative Oncology Group (ECOG) score 0-1.
  • 9. Expected lifetime≥ 3 months.
  • 10. Female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to randomization; patients must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women are not breastfeeding; male patients must agree to contraception and refuse sperm donation.
  • 11. Fully understand this clinical trial and willing to sign a written informed consent form.

Who cannot join

  • 1. Medical history of other malignant tumors or other active malignant tumors within 5 years prior to randomization (cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included).
  • 2. Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 14 days before randomization (Additional intervention is required within 2 weeks after intervention, such as pleural effusion, abdominal effusion, pericardial effusion, etc., excluding exfoliative cytology testing of exudate).
  • 3. Patients with central nervous system metastasis.
  • 4. Patients who have used paclitaxel/docetaxel in the past (except patients with disease progression more than one year after neoadjuvant/adjuvant treatment with paclitaxel/docetaxel).
  • 5. Patients whose previous medical history shows dMMR/MSI-H (deficient Mismatch Repair or High Microsatellite Instability) and who have not received immunotherapy in the past are not suitable for enrollment, and those whose dMMR/MSI status is unknown need to clarify the status before enrollment.
  • 6. History of serious cardiovascular or cerebrovascular disease, including but not limited to:
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  • Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc;
  • Acute coronary syndrome, congestive heart failure, stroke, or other level 3 or higher cardiovascular events occurring within 6 months before randomization;
  • The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of\<50%;
  • Long QTc syndrome or QTc interval\>480 milliseconds, as well as the use of any known concomitant medication that can prolong the QT interval;
  • Poor control of hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg during the screening period).
  • 7. History of gastrointestinal perforation and/or fistula within 6 months before randomization.
  • 8. Patients with active hepatitis B(Hepatitis B surface antigen (HBsAg) or HBcAb -positive, and in the active phase of hepatitis B (HBV-DNA ≥ 10^4 cps/mL or ≥ 2000 IU/mL)), hepatitis C(Hepatitis C antibody (Anti HCV) positive and tested positive for HCV RNA by PCR) or HIV.
  • 9. Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy within 14 days before randomization. Note: Patients with viral hepatitis are allowed to receive antiviral treatment.
  • 10. Tuberculosis treatment history within 2 years before randomization.
  • 11. Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.
  • 12. Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0) (excluding anemia, alopecia, fatigue, poor appetite, or other toxicities that the investigator deems to have no safety risk to patients).
  • 13. Received major organ surgery or invasive intervention treatment within 28 days before randomization. Or planned to undergo systematic or local tumor resection surgery during the study period.
  • 14. Received intravenous chemotherapy or biopolymer therapy within 28 days before randomization. Or received oral chemotherapy, immunotherapy (such as interleukin, interferon, thymosin, etc.), hormone therapy, small molecule targeted therapy, or any experimental intervention within 14 days or 5 half-lives (whichever is shorter) before randomization. Received traditional Chinese medicine or traditional Chinese patent medicines with anti-tumor indications within 14 days before randomization.
  • 15. Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization.
  • 16. Allergic to and/or contraindication to albumin or docetaxel.
  • 17. Known allergy and/or contraindication to glucocorticoids (including but not limited to active gastrointestinal ulcers, severe hypertension, severe hypokalemia, glaucoma, etc).
  • 18. Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence/alcohol dependence.
  • 19. Patients participated in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or is in the follow-up period of an intervention study.
  • 20. Other situations that the investigator thinks are not suitable for patients in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-31169085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • CSPC Zhongqi Technology(SJZ) Ltd

    Shijiazhuang, Hebei, 050035

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled Phase III Clinical Study of Docetaxel for Injection (Albumin-bound) Versus Taxotere in Gastric Cancer

This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.

Read the detailed description

About 630 patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.

Conditions
Gastric Cancer
Being tested
Docetaxel for injection (Albumin-bound), Taxotere (docetaxel)
Medical subject headings
Stomach Neoplasms

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

    Also called HB1801

    Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks

  • Taxotere (docetaxel)Drug

    Also called Taxotere

    Taxotere, by intravenous infusion, every 3 weeks.

Study groups in NCT06296706
Study groupRoleWhat they receive
Docetaxel for Injection (Albumin-bound)ExperimentalDocetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks.
Receives: Drug: Docetaxel for injection (Albumin-bound)
Taxotere (Docetaxel)Active comparatorTaxotere will be administrated by intravenous infusion once every 3 weeks.
Receives: Drug: Taxotere (docetaxel)

What is being measured

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

  1. OS

    Overall survival (OS)

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

Secondary outcomes (6)

  1. ORR

    Overall response rate (ORR)

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

  2. PFS

    Progression-Free-Survival (PFS)

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

  3. DCR

    Disease control rate (DCR)

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

  4. DoR

    Duration of Response (DoR)

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

  5. The incidence and severity of adverse events (AE) and severe adverse events (SAE)

    The incidence and severity of adverse events (AE) and severe adverse events (SAE)

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

  6. Plasma concentration of docetaxel (free and total)

    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 posted6 Mar 2024
  2. Study start27 Feb 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2027 (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
Masking
None (open label)
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06296706
Sponsor's protocol ID
HB1801-010
Status last verified
Nov 2024
First submitted
28 Feb 2024
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel for injection (Albumin-bound) and Taxotere (docetaxel) in people with Gastric Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 11 inclusion and 25 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 14 Nov 2024. 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 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 (86-31169085587, 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: At the end of Cycle 1(each cycle is 21 days)). 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 NCT06296706.

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 14 Nov 2024.

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