Solid TumorNCT06512896
Clinical Study on Intraluminal Injection of FOLactis
A study testing FOLactis in people with Solid Tumor and Immune Response, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Immune Response, Pleural Effusion, Malignant
- What is being tested?
- FOLactis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 May 2026
- Phase
- Interventional
- 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
- Age range from 18 to 80 years old, both male and female;
- Eastern Cooperative Oncology Group Performance Status score 0-2 poinRecurrent or metastatic solid tumors confirmed by pathology (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, liver cancer, cholangiocarcinoma, gastrointestinal stromal tumor, head and neck tumor, gastric cancer, bone and soft tissue sarcoma, neuroendocrine tumor, etc.);
- Malignant pleural/abdominal effusion confirmed by pathology;
- Expected survival time ≥ 12 weeks;
- The main organ function and bone marrow function are normal, meeting the following requirements:
- Hemoglobin ≥ 80 g/L (no blood transfusion within 14 days);
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- Absolute neutrophil count ≥ 1.5 × 109/L, and white blood cell count ≥ 3 × 109/L;
- Platelet count ≥ 90 × 109/L;
- If there is no liver metastasis, total bilirubin<1.5 × ULN; If there is liver metastasis or Gilbert syndrome in patients with high indirect bilirubinemia, total bilirubin<3 × ULN;
- If there is no confirmed liver metastasis, AST and ALT<2.5 × ULN; If there is confirmed liver metastasis, AST and ALT<5 × ULN;
- Serum creatinine ≤ 1.5 × The upper limit of normal value (ULN) and the creatinine clearance rate calculated by the Cockroft Fault formula * are ≥ 30 mL/min;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- International standardized ratio (INR)<1.5, and activated partial prothrombin time (APTT)<1.5 × ULN.
- The interval between previous anti-tumor therapy and the first administration of this trial is ≥ 4 weeks, and the toxicity related to anti-tumor therapy has returned to ≤ 1 level (excluding hair loss, vitiligo, stable hypothyroidism after hormone replacement therapy, etc.);
- Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 3 months after the last administration of the study medication should be considered;
- Those who voluntarily participate and sign an informed consent form, and are willing to follow the experimental treatment plan and visit plan;
- Agree to provide blood samples, pleural/ascitic fluid samples, and histological specimens.
Who cannot join
- Within 4 weeks prior to enrollment, major surgeries were performed (excluding outpatient minor surgeries such as placement of vascular pathways);
- Even after medication treatment, hypertension is still not well controlled (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
- Suffering from uncontrollable clinical symptoms or diseases of the heart, including: (1) NYHA II and above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias who require clinical intervention;
- Having any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy);
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other therapeutic hormones), and continues to use them within 2 weeks before enrollment;
- Has experienced severe allergic reactions to other monoclonal antibodies; Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or undergoing thrombolytic or anticoagulant treatment, allowing prophylactic use of low-dose aspirin and low molecular weight heparin;
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- HIV positive; HCV positive; Uncontrolled active hepatitis B;
- Severe infection (such as requiring intravenous drip of antibiotics, antifungal or antiviral drugs) within 2 weeks before the first medication, or unexplained fever>38.5 ℃ during screening/before the first medication;
- Arterial/venous thrombotic events that occurred within 6 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Known to be allergic to any investigational drug;
- Pregnant and lactating patients, as well as those with reproductive ability, are unwilling to take effective contraceptive measures;
- Has a clear history of neurological or mental disorders, including epilepsy and dementia;
- Other situations that the researchers believe are not suitable for inclusion. Including but not limited to factors such as family or society, which can affect the safety of the subjects or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Medical School of Nanjing University & Clinical Center Institute of Nanjing University, Nanjing, China
Nanjing
Shu Su, 02583106666, ssnine@126.com
About this study
Official title: Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Intraluminal Injection of FOLactis in Patients With Advanced Solid Tumors Accompanied by Malignant Pleural and Peritoneal Effusion
This clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. The safety, tolerability and preliminary efficacy of intraluminal injection of FOLactis combined with systemic anti-tumor therapy will be evaluated.
- Being tested
- FOLactis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLactisOther
Also called chemo therapy, target therapy, programmed cell and death protein 1
Evaluate the safety,tolerability, efficacy of intraluminal injection of FOLactis combined with chemotherapy, target therapy, and immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| The safety and tolerability of intraluminal injection of FOLactis | Other | Evaluate the safety and tolerability of intraluminal injection of FOLactis combined with systemic anti-tumor therapy in patients with advanced solid tumors accompanied by malignant pleural and peritoneal effusion, determine the optimal dose, and explore preliminary efficacy Receives: Other: FOLactis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Evaluate the safety and tolerability of intraluminal injection of FOLactis combined with systemic anti-tumor therapy
Measured: three years
Secondary outcomes (3)
Objective Response Rate
Observation and evaluation of the preliminary efficacy of FOLactis in patients with advanced solid tumors accompanied by malignant pleural and peritoneal effusion
Measured: three years
Progression Free Survival
Changes in the levels of cytokines and lymphocyte subsets in the pleural and peritoneal effusion/peripheral blood of subjects before and after FOLactis treatment;
Measured: three years
Overall Survival
- The changes in pleural and peritoneal effusion/peripheral blood tumor markers in subjects before and after FOLactis treatment; 2) Changes in tumor microenvironment in the chest and abdominal cavities of subjects before and after FOLactis treatment.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 May 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512896
- Sponsor's protocol ID
- ME-ISV-FOLactis
- Status last verified
- Aug 2023
- First submitted
- 8 Feb 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Intraluminal Injection of FOLactis in Patients With Advanced Solid Tumors Accompanied by Malignant Pleural and Peritoneal Effusion
- ClinicalTrials.gov ID
- NCT06512896
- Acronym / sponsor ID
- ME-ISV-FOLactis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 Jul 2024 (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 clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. The safety, tolerability and preliminary efficacy of intraluminal injection of FOLactis combined with systemic anti-tumor therapy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The safety and tolerability of intraluminal injection of FOLactis | Other | Other: FOLactisEvaluate the safety and tolerability of intraluminal injection of FOLactis combined with systemic anti-tumor therapy in patients with advanced solid tumors accompanied by malignant pleural and peritoneal effusion, determine the optimal dose, and explore preliminary efficacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age range from 18 to 80 years old, both male and female;
- Eastern Cooperative Oncology Group Performance Status score 0-2 poinRecurrent or metastatic solid tumors confirmed by pathology (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, liver cancer, cholangiocarcinoma, gastrointestinal stromal tumor, head and neck tumor, gastric cancer, bone and soft tissue sarcoma, neuroendocrine tumor, etc.);
- Malignant pleural/abdominal effusion confirmed by pathology;
- Expected survival time ≥ 12 weeks;
- The main organ function and bone marrow function are normal, meeting the following requirements:
Key exclusion criteria (13 listed)
- Within 4 weeks prior to enrollment, major surgeries were performed (excluding outpatient minor surgeries such as placement of vascular pathways);
- Even after medication treatment, hypertension is still not well controlled (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
- Suffering from uncontrollable clinical symptoms or diseases of the heart, including: (1) NYHA II and above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias who require clinical intervention;
- Having any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy);
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other therapeutic hormones), and continues to use them within 2 weeks before enrollment;
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 |
|---|---|---|
| FOLactisAlso: chemo therapy, target therapy, programmed cell and death protein 1Evaluate the safety,tolerability, efficacy of intraluminal injection of FOLactis combined with chemotherapy, target therapy, and immunotherapy | Other | The safety and tolerability of intraluminal injection of FOLactis |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: three years
Evaluate the safety and tolerability of intraluminal injection of FOLactis combined with systemic anti-tumor therapy
3 secondary outcomes
Objective Response Rate
Time frame: three years
Progression Free Survival
Time frame: three years
Overall Survival
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- 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 study testing FOLactis in people with Solid Tumor and Immune Response, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 17 inclusion and 13 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 22 Jul 2024. 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.
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 Baorui Liu, MD,PhD (02583106666, baoruiliu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: three 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 22 Jul 2024.