HER2-positive Gastric CancerPhase 1/2NCT05982834
Disitamab Vedotin, Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive MGC
A Phase 1/2 study testing Disitamab Vedotin combined with fruquintinib and Tislelizumab in people with HER2-positive Gastric Cancer and Immunotherapy, run by Fudan University at 1 site in China.
Trial summary
At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with anti-angiogenic drugs are mainly used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Gastric Cancer, Immunotherapy
- What is being tested?
- Disitamab Vedotin combined with fruquintinib and Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to Dec 2025
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than18 years of age, gender not limited;
- the histologic diagnosis of the stomach or gastroesophageal junction adenocarcinoma;
- immunohistochemical HER2 2 + 3 + or HER2, FISH is positive;
- at least have a measurable lesions (10 mm or higher spiral CT scan, RECIST 1.1 standard);
- First-line treatment failure of fluorouracil and the platinum, or to accept containing fluorouracil and platinum adjuvant chemotherapy in patients with recurrence after 6 months;
- ECOG 0-2, expected survival for 3 months or more;
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- the subjects treated with other damage has been restored, accepting radiotherapy should be ended more than 3 weeks;
- major organs function is normal, the group within 1 week before the lab test results meet the following criteria: (1) The standard of blood routine examination shall meet:
- HB≥80g/L;
- ANC ≥1.5×109/L;
- PLT ≥75×109/L (2) Biochemical examination shall meet the following standards:
- Total bilirubin BIL < 1.25 * upper limit of normal (ULN) B. the ALT and AST acuities were 2.5 * ULN. C. serum creatinine (Cr) of 1.5 or less * ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft - Gault formula)
- participants voluntarily participate in this study, and signed by himself or agent informed consent; Patient compliance is good, can cooperate with the relevant examination, treatment and follow-up.
Who cannot join
- history of other malignant tumors within 3 years, have cured except cervical carcinoma in situ or skin basal cell carcinoma;
- with brain or meningeal metastasis;
- associated with gastrointestinal obstruction, gastrointestinal bleeding (defecate occult blood + + + and above) or perforation;
- with active, or have a history and possible recurrence of autoimmune disease of the subjects (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as those who have received an organ transplant requiring immunosuppressive therapy), However, patients with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment within the last 2 years, or patients with hypothyroidism who only needed thyroid hormone replacement therapy, and patients with type I diabetes who only needed insulin replacement therapy could be enrolled;
- now with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung diseases, radiation pneumonia;
- within 4 weeks before delivery for the first time to participate in any other drug clinical research (the use of test drugs shall prevail), unless the participant observation (non intrusive) clinical research;
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- within 4 weeks before the first dose of study treatment used immunosuppressive drugs, Does not include nasal, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/ day of prednisone or equivalent doses of other corticosteroids), or short-term (not exceeding 7 days) use of corticosteroids for the prevention or treatment of non-autoimmune allergic diseases;
- within 4 weeks before the first dose of study treatment or accept the live attenuated plan during the study period. Note: Inactivated virus vaccines for injectable seasonal influenza are permitted for up to 4 weeks prior to initial administration; But live attenuated influenza vaccines are not allowed;
- within 4 weeks before the first dose of study treatment received major surgery, open chest or craniotomy laparotomy or expected during the research and treatment need to accept of this study major surgery.
- infected with human immunodeficiency virus (HIV) disease (i.e., an HIV positive), or with other acquired, congenital immunodeficiency disease, or has a history of history of organ transplantation, or stem cell transplantation;
- chronic active hepatitis b or active active hepatitis c, hepatitis b virus carriers, stable after drug treatment of hepatitis b (DNA drop degree is not higher than 200 iu/mL or copy number Copies <1000copies/mL) and cured hepatitis C patients (HCV RNA test negative) could be included;
- with known active tuberculosis;
- first before 4 weeks with severe infections, or 2 weeks before appear active infection need oral or intravenous antibiotic therapy patients;
- symptomatic congestive heart failure (New York heart association grade II - IV) or symptomatic or poorly controlled arrhythmia.
- even give specification treatment still uncontrolled arterial blood pressure (systolic blood pressure or greater acuity 160 MMHG or diastolic blood pressure, 100 MMHG).
- within 6 months before the selected treatment occurred any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- within 3 months before the group with deep vein thrombosis, pulmonary embolism, or any other serious history of thromboembolism (implantable venous infusion port source sex or catheter thrombosis, or superficial venous thrombosis were not regarded as a "severe" thromboembolism).
- always have a clear history of neurological or psychiatric disorders, such as memory, epilepsy, dementia, compliance, or the peripheral nervous system disorder;
- alcohol dependence or nearly 1 year has a history of drug or drug abuse;
- pregnancy or lactation women; Those who are fertile but do not take adequate contraceptive measures;
- may lead to the following results of other acute or chronic diseases, mental illness or abnormal laboratory values: participated in or study drug dosage associated with an increased risk, or interfere with the interpretation of results, and according to the researcher's judgment will be patient as does not conform to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaodong Zhu, Ph.D.,M.D., 64175590, xddr001@163.com
About this study
Official title: Disitamab Vedotin Combined With Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive Metastatic Gastric Cancer: A Prospective Phase Ib/II Study
At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs. Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from immunotherapy, so the investigators hope to explore the possibility of immunotherapy in second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in second-line therapy.
- Conditions
- HER2-positive Gastric Cancer, Immunotherapy
- Being tested
- Disitamab Vedotin combined with fruquintinib and Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin combined with fruquintinib and TislelizumabDrug
Disitamab Vedotin 2.5mg/m2 ivgtt d1,15, fruquintinib 4mg qd po d1-21 and Tislelizumab 300mg ivgtt,q4w
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin combined with fruquintinib and Tislelizumab | Experimental | Not described Receives: Drug: Disitamab Vedotin combined with fruquintinib and Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
the proportion of patients whose tumor dcrease to a certain size and remained for a certain period of time, including those with complete response(CR) and partial response (PR).
Measured: 8 weeks, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start9 May 2023
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982834
- Sponsor's protocol ID
- FDZL-RCPF
- Status last verified
- Aug 2023
- First submitted
- 19 May 2023
- Last updated
- 9 Aug 2023
- Results posted
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin Combined With Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive Metastatic Gastric Cancer: A Prospective Phase Ib/II Study
- ClinicalTrials.gov ID
- NCT05982834
- Acronym / sponsor ID
- FDZL-RCPF
- Conditions
- HER2-positive Gastric Cancer, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Aug 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.
At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs. Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from immunotherapy, so the investigators hope to explore the possibility of immunotherapy in second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in second-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin combined with fruquintinib and Tislelizumab | Experimental | Drug: Disitamab Vedotin combined with fruquintinib and Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- older than18 years of age, gender not limited;
- the histologic diagnosis of the stomach or gastroesophageal junction adenocarcinoma;
- immunohistochemical HER2 2 + 3 + or HER2, FISH is positive;
- at least have a measurable lesions (10 mm or higher spiral CT scan, RECIST 1.1 standard);
- First-line treatment failure of fluorouracil and the platinum, or to accept containing fluorouracil and platinum adjuvant chemotherapy in patients with recurrence after 6 months;
Key exclusion criteria (21 listed)
- history of other malignant tumors within 3 years, have cured except cervical carcinoma in situ or skin basal cell carcinoma;
- with brain or meningeal metastasis;
- associated with gastrointestinal obstruction, gastrointestinal bleeding (defecate occult blood + + + and above) or perforation;
- with active, or have a history and possible recurrence of autoimmune disease of the subjects (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as those who have received an organ transplant requiring immunosuppressive therapy), However, patients with vitiligo, psoriasis, alopecia, or Grave's disease who did not require systemic treatment within the last 2 years, or patients with hypothyroidism who only needed thyroid hormone replacement therapy, and patients with type I diabetes who only needed insulin replacement therapy could be enrolled;
- now with interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung diseases, radiation pneumonia;
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 |
|---|---|---|
| Disitamab Vedotin combined with fruquintinib and TislelizumabDisitamab Vedotin 2.5mg/m2 ivgtt d1,15, fruquintinib 4mg qd po d1-21 and Tislelizumab 300mg ivgtt,q4w | Drug | Disitamab Vedotin combined with fruquintinib and Tislelizumab |
Primary outcome
objective response rate
Time frame: 8 weeks, up to 1 year.
the proportion of patients whose tumor dcrease to a certain size and remained for a certain period of time, including those with complete response(CR) and partial response (PR).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Disitamab Vedotin combined with fruquintinib and Tislelizumab in people with HER2-positive Gastric Cancer and Immunotherapy, run by Fudan University 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 13 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 9 Aug 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiaodong Zhu, M.D.,Ph.D. (64175590, xddr001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 8 weeks, up to 1 year.). 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 9 Aug 2023.