Trial Title:
Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma.
NCT ID:
NCT05919381
Condition:
Adenocarcinoma of Stomach
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
Adenocarcinoma of stomach or gastroesophageal junction.
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Gentuximab Injection
Description:
Gentuximab Injection 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.
Arm group label:
Gentuximab Injection
Arm group label:
Gentuximab Injection Placebo
Intervention type:
Drug
Intervention name:
Gentuximab Injection Placebo
Description:
Gentuximab Injection Placebo 8 mg/kg, D1, 15 intravenous drip, a cycle every 28 days.
Arm group label:
Gentuximab Injection
Arm group label:
Gentuximab Injection Placebo
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.
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):
1. 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.
2. 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
•• 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Dongfang Hospital
Address:
City:
Shanghai
Zip:
200135
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Li
Phone:
+86 13761222111
Email:
lijin@csco.org.cn
Start date:
May 30, 2022
Completion date:
January 2025
Lead sponsor:
Agency:
Changchun GeneScience Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Changchun GeneScience Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919381
