Gastric AdenocarcinomaPhase 2NCT05705635
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer
A Phase 2 study testing Docetaxel for injection (Albumin-bound) and Taxotere in people with Gastric Adenocarcinoma and Adenocarcinoma of Gastroesophageal Junction, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Adenocarcinoma of Gastroesophageal Junction
- What is being tested?
- Docetaxel for injection (Albumin-bound) and Taxotere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2023to Dec 2024
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form).
- Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests.
- Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
- Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
- Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
- Adequate main organ function.
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- Eastern Cooperative Oncology Group (ECOG) score 0-1.
- Expected lifetime≥ 3 months.
- 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.
- At least one assessable lesion according to RECIST V1.1; The area should not have received radiotherapy in the past, or there is evidence that the lesion has made definite progress after radiotherapy.
Who cannot join
- Other active malignant tumors in the first 5 years of randomization.
- Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization.
- Patients with central nervous system metastasis.
- Patients whose previous medical history shows dMMR/MSI-H 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 enrolment.
- 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).
- History of serious cardiovascular disease within 6 months before randomization.
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- History of gastrointestinal perforation and/or fistula within 6 months before randomization.
- Hypertension with poor control during the screening period.
- Patients with active hepatitis B, hepatitis C or HIV.
- Patients with severe chronic or active infections that require systemic antimicrobial, antifungal, or antiviral therapy.
- Patients with gastrointestinal obstruction and active inflammatory bowel disease within 28 days before randomization.
- Toxic reaction caused by any previous treatment has not recovered to level 1 or below (CTCAE5.0).
- Major organ surgery (except puncture biopsy) within 28 days before randomization.
- Have received chemotherapy, radiotherapy, targeted therapy, immunotherapy or other anti-tumor treatment of clinical research drugs within 28 days before randomization.
- Have received traditional Chinese medicine with anti-tumor indications within 14 days before randomization.
- Have received powerful CYP3A4 inhibitor or inducer within 14 days before randomization.
- Allergic to and / or contraindication to albumin or docetaxel.
- Known allergy and/or contraindication to glucocorticoids.
- Patients with psychiatric neurological disorders that may affect trial adherence, or patients with a history of drug dependence / alcohol dependence.
- Other situations that the researcher thinks are not suitable for participating in this study.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Sun-Yat-Sen University Cancer Center
Guangzhou
Ruihua Xu
About this study
Official title: A Multicenter, Randomized, Controlled Phase II Clinical Study of Comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in Second-line or Above Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
This trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Read the detailed description
One hundred 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.
- Being tested
- Docetaxel for injection (Albumin-bound), Taxotere
- Keywords
- gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound
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.
TaxotereDrug
Taxotere, by intravenous infusion, every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel for Injection (Albumin-bound) | Experimental | Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks. Receives: Drug: Docetaxel for injection (Albumin-bound) |
| Taxotere | Active comparator | Taxotere will be administrated by intravenous infusion once every 3 weeks. Receives: Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival (PFS)
The duration is from the randomized time to disease progression or death due to any reason.
Measured: Up to approximately 2 years
Secondary outcomes (5)
Overall response rate (ORR)
The primary endpoint is objective response rate,which equals CR+PR.
Measured: Up to approximately 2 years
Disease control rate (DCR)
The primary endpoint is Disease Control rate,which equals CR+PR+SD.
Measured: Up to approximately 2 years
Duration of Response (DoR)
The time from the first assessment of tumor as CR or PR to the first assessment as PD or death from any cause
Measured: Up to approximately 2 years
Overall survival (OS)
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
Measured: Up to approximately 2 years
Incidence of AE and SAE
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start13 Jan 2023
- Primary completionMay 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705635
- Sponsor's protocol ID
- HB1801-007
- Status last verified
- Jan 2023
- First submitted
- 22 Nov 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Phase II Clinical Study of Comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in Second-line or Above Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05705635
- Acronym / sponsor ID
- HB1801-007
- Keywords
- gastric adenocarcinoma, gastroesophageal junction adenocarcinoma,Docetaxel,Albumin-bound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2023 (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 trial is a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Detailed description
One hundred 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel for Injection (Albumin-bound) | Experimental | Drug: Docetaxel for injection (Albumin-bound)Docetaxel for Injection (Albumin-bound) will be administrated by intravenous infusion once every 3 weeks. |
| Taxotere | Active comparator | Drug: TaxotereTaxotere will be administrated by intravenous infusion once every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-75 (inclusive) (Whichever is on the day of signing the informed consent form).
- Willing to sign the informed consent form, willing and able to follow the program to accept visits, treatment and laboratory tests.
- Gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction confirmed by histology or cytology.
- Locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction after receiving at least first-line systematic treatment (defined as platinum/fluorouracil containing dual drug chemotherapy, with or without immunotherapy).
- Previous history with positive Her-2 expression requires anti-Her-2 medication; unknown Her-2 expression should define Her-2 status before enrollment.
Key exclusion criteria (21 listed)
- Other active malignant tumors in the first 5 years of randomization.
- Uncontrolled serous cavity effusion requiring frequent drainage or medical intervention within 7 days before randomization.
- Patients with central nervous system metastasis.
- Patients whose previous medical history shows dMMR/MSI-H 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 enrolment.
- 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).
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 |
|---|---|---|
| Docetaxel for injection (Albumin-bound)Docetaxel for injection (Albumin-bound), by intravenous infusion, every 3 weeks. | Drug | Docetaxel for Injection (Albumin-bound) |
| TaxotereTaxotere, by intravenous infusion, every 3 weeks. | Drug | Taxotere |
Primary outcome
Progression-Free-Survival (PFS)
Time frame: Up to approximately 2 years
The duration is from the randomized time to disease progression or death due to any reason.
5 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Incidence of AE and SAE
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Ruihua Xu study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel for injection (Albumin-bound) and Taxotere in people with Gastric Adenocarcinoma and Adenocarcinoma of Gastroesophageal Junction, 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 10 inclusion and 21 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 31 Jan 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ruihua Xu (+86-20-87343468, xurh@sysucc.org.cn), 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: 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?
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 31 Jan 2023.