Gastric CancerPhase 2NCT06437678
Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer
A Phase 2 study testing Liposomal Irinotecan Hydrochloride in people with Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Liposomal Irinotecan Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 28 Feb 2026
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily join this study and sign an informed consent form;
- Age ≥18 years and ≤75 years;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
- CT or biopsy-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Previously received at least one line of standard first- and second-line therapy (e.g., chemotherapy, targeted therapy), and experienced disease progression or intolerance;
- Interval of ≥4 weeks since previous chemotherapy, immunotherapy, or radiotherapy;
Show all 16Show fewer
- Expected survival of ≥12 weeks;
- ECOG performance status score of 0-2;
- Normal major organ function, meeting the following criteria:
- Hematologic criteria:
- (No blood transfusion or blood products, and no use of G-CSF or other hematopoietic growth factors within 14 days) Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥80×10^9/L; Hemoglobin ≥80 g/L.
- Biochemical criteria:
- Total bilirubin <1.5×ULN; ALT and AST ≤2.5×ULN (without liver metastasis) / ALT and AST ≤5×ULN (with liver metastasis); Serum creatinine ≤1.5×ULN or creatinine clearance >50 ml/min (Male: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine); Female: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine) × 0.85; weight in kg; serum creatinine in mg/mL).
- Urine protein (semi-quantitative method) less than 2+;
- Normal coagulation function (including INR, APTT, PT, FIB).
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for 120 days after the last dose. Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for 120 days after the last dose.
Who cannot join
- Having a history of or currently suffering from other malignant tumors;
- Previous or current use of irinotecan drugs;
- Having any chronic or significant disease deemed intolerable to treatment (e.g., severe heart disease, uncontrolled hypertension, significant liver or kidney dysfunction, etc.);
- History of gastrointestinal perforation, abdominal abscess, or recent (within 3 months) bowel obstruction, or imaging or clinical symptoms indicating the presence of bowel obstruction;
- Significant clinically relevant bleeding symptoms or a clear tendency to bleed within 3 months before the first dose of the study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; if fecal occult blood is positive at baseline, retesting is allowed. If retesting remains positive, a gastroscopy is required (unless gastroscopy has been performed within the past 3 months to exclude these conditions);
- Currently undergoing treatment for an active infection (e.g., requiring antibacterial, antiviral, or antifungal therapy);
Show all 16Show fewer
- Active hepatitis (Hepatitis B: HBsAg positive and HBV DNA ≥500 IU/ml; Hepatitis C: HCV antibody positive and HCV RNA > upper limit of normal);
- Congenital or acquired immunodeficiency (e.g., HIV infection);
- Suffering from a mental illness that could interfere with consent or follow-up;
- Having any active autoimmune disease or a history of autoimmune disease with a risk of recurrence;
- Planned or previous organ or allogeneic bone marrow transplantation;
- Currently having interstitial pneumonia or interstitial lung disease, a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or a screening CT showing active pneumonia or severe lung dysfunction; active tuberculosis;
- Currently using or recently used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes;
- Received an attenuated live vaccine within 28 days before the first dose of the study drug, or requires such a vaccine during the treatment period or within 60 days after the last dose;
- Known allergy to any study drug or excipients;
- Breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang
About this study
Official title: A Single-Center, Prospective Phase II Clinical Study of Liposomal Irinotecan Monotherapy for Third-Line and Beyond Recurrent/Refractory Advanced Gastric Cancer
To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.
Read the detailed description
This study is a single-arm, single-center, prospective clinical trial aimed at evaluating the efficacy and safety of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. The study targets patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. The primary endpoints of the study are objective response rate (ORR) and disease control rate (DCR). It plans to enroll 50 patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. Subjects will sign informed consent and undergo screening for eligibility before enrollment. Subjects will receive the following treatment: Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks. Safety visits will be conducted on Day 1 of each treatment cycle, at the end of the study treatment, and 30 days (±7 days) after the end of the study treatment. Imaging assessments will be performed according to RECIST 1.1 criteria, including chest CT, enhanced CT scans of the abdomen and pelvis, or chest CT plain scan plus abdominal/pelvic MRI scan for patients allergic to contrast agents. Suspected cases of brain metastases will require brain enhanced MRI or enhanced CT. Bone scan examination will be conducted if bone metastases are suspected clinically or radiologically. Patients who discontinue treatment due to reasons other than radiological progression during the treatment period will undergo imaging examination at the end of treatment unless it has been conducted within 28 days. Subjects will undergo survival follow-up every 3 months after the end of treatment to collect and record survival status and subsequent anti-tumor treatment until death or loss to follow-up.
- Conditions
- Gastric Cancer
- Being tested
- Liposomal Irinotecan Hydrochloride
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Irinotecan HydrochlorideDrug
Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Recurrent/Refractory Advanced Gastric Cancer | Other | Not described Receives: Drug: Liposomal Irinotecan Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
After treatment, the proportion of cancer patients whose tumors have shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of the complete response (CR) and partial response (PR) ratios.
Measured: through study completion, an average of 1 year
Disease Control Rate (DCR)
The percentage of evaluable cases in cancer patients who have improved their condition (CR+PR) and stabilized their condition (SD) after treatment.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
OS (Overall survival)
The time between the date of enrollment and death caused by any reason.
Measured: Assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start27 May 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Xiangdong Cheng, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437678
- Sponsor's protocol ID
- IRB-2024-498
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 31 May 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Phase II Clinical Study of Liposomal Irinotecan Monotherapy for Third-Line and Beyond Recurrent/Refractory Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06437678
- Acronym / sponsor ID
- IRB-2024-498
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 27 May 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 31 May 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.
To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.
Detailed description
This study is a single-arm, single-center, prospective clinical trial aimed at evaluating the efficacy and safety of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. The study targets patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. The primary endpoints of the study are objective response rate (ORR) and disease control rate (DCR). It plans to enroll 50 patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. Subjects will sign informed consent and undergo screening for eligibility before enrollment. Subjects will receive the following treatment: Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks. Safety visits will be conducted on Day 1 of each treatment cycle, at the end of the study treatment, and 30 days (±7 days) after the end of the study treatment. Imaging assessments will be performed according to RECIST 1.1 criteria, including chest CT, enhanced CT scans of the abdomen and pelvis, or chest CT plain scan plus abdominal/pelvic MRI scan for patients allergic to contrast agents. Suspected cases of brain metastases will require brain enhanced MRI or enhanced CT. Bone scan examination will be conducted if bone metastases are suspected clinically or radiologically. Patients who discontinue treatment due to reasons other than radiological progression during the treatment period will undergo imaging examination at the end of treatment unless it has been conducted within 28 days. Subjects will undergo survival follow-up every 3 months after the end of treatment to collect and record survival status and subsequent anti-tumor treatment until death or loss to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent/Refractory Advanced Gastric Cancer | Other | Drug: Liposomal Irinotecan Hydrochloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients voluntarily join this study and sign an informed consent form;
- Age ≥18 years and ≤75 years;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
- CT or biopsy-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Previously received at least one line of standard first- and second-line therapy (e.g., chemotherapy, targeted therapy), and experienced disease progression or intolerance;
Key exclusion criteria (16 listed)
- Having a history of or currently suffering from other malignant tumors;
- Previous or current use of irinotecan drugs;
- Having any chronic or significant disease deemed intolerable to treatment (e.g., severe heart disease, uncontrolled hypertension, significant liver or kidney dysfunction, etc.);
- History of gastrointestinal perforation, abdominal abscess, or recent (within 3 months) bowel obstruction, or imaging or clinical symptoms indicating the presence of bowel obstruction;
- Significant clinically relevant bleeding symptoms or a clear tendency to bleed within 3 months before the first dose of the study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; if fecal occult blood is positive at baseline, retesting is allowed. If retesting remains positive, a gastroscopy is required (unless gastroscopy has been performed within the past 3 months to exclude these conditions);
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 |
|---|---|---|
| Liposomal Irinotecan HydrochlorideLiposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks | Drug | Recurrent/Refractory Advanced Gastric Cancer |
Primary outcome
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
After treatment, the proportion of cancer patients whose tumors have shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of the complete response (CR) and partial response (PR) ratios.
Disease Control Rate (DCR)
Time frame: through study completion, an average of 1 year
The percentage of evaluable cases in cancer patients who have improved their condition (CR+PR) and stabilized their condition (SD) after treatment.
1 secondary outcome
OS (Overall survival)
Time frame: Assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Xiangdong Cheng study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Irinotecan Hydrochloride in people with Gastric Cancer, run by Zhejiang Cancer Hospital 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 16 inclusion and 16 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 31 May 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.
What does this phase mean?
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 Xiangdong Cheng (13968032995, chengxd@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 31 May 2024.