New drug combo shows promise for tough stomach cancers
NCT ID NCT04053205
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new drug called gentuximab combined with the chemotherapy drug paclitaxel in 76 people with advanced stomach or gastroesophageal junction cancer that had worsened after initial treatment. The goal was to find a safe and effective dose and see if the combination could shrink tumors or slow the cancer's growth. The trial focused on safety and early signs of benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gentuximab (a drug) combined with paclitaxel (a chemotherapy drug)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced gastric cancer that has stopped responding to initial chemotherapy.
- What could go wrong
- This is an early-phase trial with only 76 participants, so results may not apply to everyone. The combination may cause significant side effects, and it is not yet known if it improves survival compared to standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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76 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Sep 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent. * Male or female. aged between 18 and 75 years * Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium). * At least one Measurable lesion. * ECOG Performance status (PS) score, 0-1 level. * A life expectancy of \>3 months. * Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L. * Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN). * Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level\> 1.5 × ULN. * Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN. * 24-hour urine protein quantitation is \<1g(24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit). * Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment. Exclusion Criteria: * Previously administrated with anti-angiogenic drugs or paclitaxel. * Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose,Chinese medicine with anti-cancer indications is within 2 weeks before the first dose. * Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit. * Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy), or would undergo planned surgery during the study. * Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA \> ULN. * Patients with previously confirmed malignant tumors. * History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening, or the investigator determines that there is a risk of bleeding. * History of severe cardiovascular and cerebrovascular diseases. * Subjects with confirmed brain tumor metastases,but subjects in steady situation can be enrolled. * Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test. * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit. * Thoracic,abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms. * Has a nonhealing wound, serious ulcer, or unrecovered bone fracture. * Active infections requiring systemic treatment, including but not limited to active tuberculosis. * Using anticoagulation and antiplatelet drugs. * Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating. * Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction. * Has known alcohol or drug dependency.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fujian Tumor Hospital
Fuzhou, Fujian, China
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Jiangsu Province Hospital
Nanjing, Jiangsu, China
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Shanghai East Hospital
Shanghai, China
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Shanghai First People's Hospital
Shanghai, China
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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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The First Hospital of Jilin University
Changchun, Jilin, China
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The Sixth Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
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Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Hangzhou, Zhejiang, China
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Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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Other studies related to the condition(s) this trial covers.
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- Real-World check: does adding nivolumab to chemo help stomach cancer patients?