Adenocarcinoma of StomachPhase 3NCT05919381
Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.
A Phase 3 study testing Gentuximab Injection in people with Adenocarcinoma of Stomach, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of the combination of Gentuximab Injection and Paclitaxel Injection in patients with advanced gastric or gastroesophageal junction adenocarcinoma after first-line treatment failure compared with Placebo and Paclitaxel Injection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of Stomach
- What is being tested?
- Gentuximab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 752 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to Jan 2025
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18~75 years old (including boundary value), male and female.
- Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma diagnosed by histology have developed disease after receiving first-line treatment containing platinum and fluorouracil for at least one cycle.
- It is necessary to make sure that the Her-2 expression status is negative or Her-2 positive and fails to be treated with anti-Her-2 targeted drugs.
- There is at least one measurable focus according to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors.
- The physical condition score of the Eastern Cancer Cooperation Group (ECOG) was 0 or 1.
- The expected life is at least 3 months.
- Weight ≥ 40 kg, or BMI ≥ 17.
Who cannot join
- •• Have received any systemic treatment targeting VEGF or VEGFR signal pathway.
- Have received systemic treatment of paclitaxel, docetaxel and paclitaxel for injection (albumin binding type).
- Those who are allergic to antibody-like recombinant protein drugs, paclitaxel and its excipients.
- Have received chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy and other systemic anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the drug.
- Have undergone major surgery within 4 weeks before the first administration.
- Thromboembolism occurred within 6 months before screening.
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- Be receiving anticoagulant treatment with warfarin or similar preparations.
- Severe hemorrhagic disease, vasculitis or gastrointestinal bleeding within 3 months before screening.
- There was a history of gastrointestinal perforation and/or fistula, a history of intestinal obstruction, and a history of inflammatory bowel disease within 6 months before screening.
- Have a serious history of cardiovascular disease.
- Symptomatic central nervous system metastasis.
- Other malignant tumors confirmed and/or requiring treatment in the past 3 years.
- Be suffering from infectious diseases.
- Have an immune system disease or mental illness that requires treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Dongfang Hospital
Shanghai, Shanghai Municipality, 200135
Jin Li, +86 13761222111, lijin@csco.org.cn
About this study
Official title: A Randomized, Double-blind, Parallel Controlled Phase III Study of Gentuximab Injection Combined With Paclitaxel Injection Versus Placebo Combined With Paclitaxel Injection for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
To evaluate the efficacy and safety of the combination of Gentuximab Injection and Paclitaxel Injection in patients with advanced gastric or gastroesophageal junction adenocarcinoma after first-line treatment failure compared with Placebo and Paclitaxel Injection.
Read the detailed description
It was planned to enroll 752 subjects, grouped according to a 1:1 ratio, with 376 cases each in the experimental group and the control group.
Screening period:
Screening period assessments were performed within 28 days prior to randomization. Patients are screened after signing the informed consent form (ICF), complete relevant laboratory tests and imaging evaluations (including physical examination, vital signs, height, weight, ECOG score, laboratory tests, 12-lead ECG, echocardiography, chest, abdomen, pelvic contrast/contrast CT and head enhancement MRI, whole body bone scan, etc.), and subjects who meet the inclusion criteria and do not meet the exclusion criteria can be enrolled.
Treatment period:
All eligible participants were randomly assigned to the following two groups in a 1:1 ratio based on stratified factors (time to randomization < 6 months or ≥ months from the start of first-line therapy):
- Test group: Gentuximab injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days.
- Control group: placebo 8 mg/kg, D1, 15 intravenous drip, combined with paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days.
Efficacy and quality of life scores were assessed every 8 weeks ± 7 days according to RECIST 1.1, including chest, abdomen, and pelvis. The safety profile of subjects throughout treatment was evaluated according to NCI-CTCAE V 5.0 criteria, including vital signs, physical examination, ECOG score, laboratory tests, 12-lead ECG, echocardiogram, adverse events, serious adverse events, etc.
Follow-up periods:
Follow-up periods include safety and survival follow-up, immediately after the last study drug is completed.
Safety follow-up: All subjects had a safety follow-up within 28±5 days after the last dose or before starting new antitumor therapy (except for subjects withdrawing informed consent, voluntary withdrawal, loss to follow-up, death, etc.), and performed vital signs, physical examination, weight, ECG score, 12-lead ECG, laboratory tests, etc. (see Table 1.3-1 for details), and recorded concomitant medication and adverse events. If safe follow-up is less than 14 days from the end of treatment (EOT) visit, EOT visit can be an alternative to safe follow-up without repeating.
Survival follow-up: For any subject who ends treatment due to non-disease progression (and does not take other antitumor therapy), it is still necessary to return to the hospital every 8 weeks ± 7 days according to the original tumor evaluation plan for tumor imaging evaluation and life scale evaluation until disease progression, start of new antitumor therapy, withdrawal of informed consent, voluntary withdrawal, loss to follow-up, death, etc. For participants whose disease has progressed or who have started new antineoplastic therapy, survival follow-up is recorded every 8 weeks ±7 days from the time of notification of disease progression or initiation of new antineoplastic therapy (telephone follow-up) and details of subsequent treatment regimens (antineoplastic therapy received after the end of the study drug) until death, loss to follow-up, or the end of the study (whichever occurs first).
- Conditions
- Adenocarcinoma of Stomach
- Being tested
- Gentuximab Injection, Gentuximab Injection Placebo
- Keywords
- Adenocarcinoma of stomach or gastroesophageal junction.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentuximab InjectionDrug
Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.
Gentuximab Injection PlaceboDrug
Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Gentuximab Injection | Experimental | Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days. Receives: Drug: Gentuximab Injection; Drug: Gentuximab Injection Placebo |
| Gentuximab Injection Placebo | Placebo comparator | Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days. Receives: Drug: Gentuximab Injection; Drug: Gentuximab Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
From date of randomization until the date of first documented death from any cause,assessed up to 36 months.
Measured: 36 months.
Secondary outcomes (2)
PFS
From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 36 months.
Measured: 36 months.
TTF ORR DCR DOR
TTF:From date of randomization until the date of first documented progression or date of death from any cause or date of discontinuation of treatment due to AE, refusal of treatment, or other reasons (excluding due to good outcomes) ,whichever came first, assessed up to 36 months.
ORR: Overall optimal response was the proportion of participants with CR or PR, assessed up to 36 months.
DCR: From date of first assessment is CR or PR to the first assessment is PD or death from any cause, whichever came first, assessed up to 36 months.
DOR: Overall optimal response was the proportion of participants with CR or PR or SD, assessed up to 36 months.
Measured: 36 months. 36 months. 36 months. 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start30 May 2022
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of StomachStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Principal investigator, Shanghai Dongfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919381
- Sponsor's protocol ID
- Gensci043-GC-III01
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Drugs belong to the sponsor before they are put into clinical trials and the site is only a contract research organization; It is an industry practice that intellectual property rights belong to the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Controlled Phase III Study of Gentuximab Injection Combined With Paclitaxel Injection Versus Placebo Combined With Paclitaxel Injection for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT05919381
- Acronym / sponsor ID
- Gensci043-GC-III01
- Conditions
- Adenocarcinoma of Stomach
- Keywords
- Adenocarcinoma of stomach or gastroesophageal junction.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Jun 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.
To evaluate the efficacy and safety of the combination of Gentuximab Injection and Paclitaxel Injection in patients with advanced gastric or gastroesophageal junction adenocarcinoma after first-line treatment failure compared with Placebo and Paclitaxel Injection.
Detailed description
It was planned to enroll 752 subjects, grouped according to a 1:1 ratio, with 376 cases each in the experimental group and the control group.
Screening period:
Screening period assessments were performed within 28 days prior to randomization. Patients are screened after signing the informed consent form (ICF), complete relevant laboratory tests and imaging evaluations (including physical examination, vital signs, height, weight, ECOG score, laboratory tests, 12-lead ECG, echocardiography, chest, abdomen, pelvic contrast/contrast CT and head enhancement MRI, whole body bone scan, etc.), and subjects who meet the inclusion criteria and do not meet the exclusion criteria can be enrolled.
Treatment period:
All eligible participants were randomly assigned to the following two groups in a 1:1 ratio based on stratified factors (time to randomization < 6 months or ≥ months from the start of first-line therapy):
- Test group: Gentuximab injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days.
- Control group: placebo 8 mg/kg, D1, 15 intravenous drip, combined with paclitaxel injection 80 mg/m2/time, D1, 8, 15 intravenous drip, every 28 days.
Efficacy and quality of life scores were assessed every 8 weeks ± 7 days according to RECIST 1.1, including chest, abdomen, and pelvis. The safety profile of subjects throughout treatment was evaluated according to NCI-CTCAE V 5.0 criteria, including vital signs, physical examination, ECOG score, laboratory tests, 12-lead ECG, echocardiogram, adverse events, serious adverse events, etc.
Follow-up periods:
Follow-up periods include safety and survival follow-up, immediately after the last study drug is completed.
Safety follow-up: All subjects had a safety follow-up within 28±5 days after the last dose or before starting new antitumor therapy (except for subjects withdrawing informed consent, voluntary withdrawal, loss to follow-up, death, etc.), and performed vital signs, physical examination, weight, ECG score, 12-lead ECG, laboratory tests, etc. (see Table 1.3-1 for details), and recorded concomitant medication and adverse events. If safe follow-up is less than 14 days from the end of treatment (EOT) visit, EOT visit can be an alternative to safe follow-up without repeating.
Survival follow-up: For any subject who ends treatment due to non-disease progression (and does not take other antitumor therapy), it is still necessary to return to the hospital every 8 weeks ± 7 days according to the original tumor evaluation plan for tumor imaging evaluation and life scale evaluation until disease progression, start of new antitumor therapy, withdrawal of informed consent, voluntary withdrawal, loss to follow-up, death, etc. For participants whose disease has progressed or who have started new antineoplastic therapy, survival follow-up is recorded every 8 weeks ±7 days from the time of notification of disease progression or initiation of new antineoplastic therapy (telephone follow-up) and details of subsequent treatment regimens (antineoplastic therapy received after the end of the study drug) until death, loss to follow-up, or the end of the study (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentuximab Injection | Experimental | Drug: Gentuximab Injection, Drug: Gentuximab Injection PlaceboGentuximab Injection 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days. |
| Gentuximab Injection Placebo | Placebo comparator | Drug: Gentuximab Injection, Drug: Gentuximab Injection PlaceboGentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, combined with Paclitaxel Injection 80 mg/m2/time, D1, 8, 15 intravenous drip, a cycle every 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18~75 years old (including boundary value), male and female.
- Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma diagnosed by histology have developed disease after receiving first-line treatment containing platinum and fluorouracil for at least one cycle.
- It is necessary to make sure that the Her-2 expression status is negative or Her-2 positive and fails to be treated with anti-Her-2 targeted drugs.
- There is at least one measurable focus according to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors.
- The physical condition score of the Eastern Cancer Cooperation Group (ECOG) was 0 or 1.
Key exclusion criteria (14 listed)
- •• Have received any systemic treatment targeting VEGF or VEGFR signal pathway.
- Have received systemic treatment of paclitaxel, docetaxel and paclitaxel for injection (albumin binding type).
- Those who are allergic to antibody-like recombinant protein drugs, paclitaxel and its excipients.
- Have received chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy and other systemic anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the drug.
- Have undergone major surgery within 4 weeks before the first administration.
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 |
|---|---|---|
| Gentuximab InjectionGentuximab Injection 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days. | Drug | Gentuximab Injection, Gentuximab Injection Placebo |
| Gentuximab Injection PlaceboGentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days. | Drug | Gentuximab Injection, Gentuximab Injection Placebo |
Primary outcome
OS
Time frame: 36 months.
From date of randomization until the date of first documented death from any cause,assessed up to 36 months.
2 secondary outcomes
PFS
Time frame: 36 months.
TTF ORR DCR DOR
Time frame: 36 months. 36 months. 36 months. 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No. Drugs belong to the sponsor before they are put into clinical trials and the site is only a contract research organization; It is an industry practice that intellectual property rights belong to the sponsor.
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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.
Jin Li principal investigator
Shanghai Dongfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gentuximab Injection in people with Adenocarcinoma of Stomach, run by Changchun GeneScience Pharmaceutical 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 7 inclusion and 14 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 26 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Feng (+86 13917827726, fengshaohua@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 36 months.). 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 26 Jun 2023.