Advanced Gastric CancerPhase 1/2NCT06592287
The Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer
A Phase 1/2 study testing Adebrelimab + Apatinib + Lrinotecan liposome in people with Advanced Gastric Cancer, run by Xianglin Yuan at 1 site in China.
Trial summary
This study is a prospective, dual arm, open Ib/II phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer. The study is divided into two stages. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Adebrelimab + Apatinib + Lrinotecan liposome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 30 Sep 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18 to 75 years old, both male and female are acceptable;
- Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- Patients who have only received one failed systemic treatment for advanced diseases in the past; After undergoing immunotherapy, the PFS of the treatment regimen containing immune checkpoint inhibitors must be greater than 7 months;
- According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);
- ECOG score: 0-1 point;
- Expected survival period ≥ 12 weeks;
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- The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);
- Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Adebrelimab, at least 6 months after the last use of Apatinib, and at least 6 months after the last use of chemotherapy;
- HER2 negative;
- Voluntarily join this study, sign informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
- There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
- Have a history of allergies to any component of Adebrelimab in the past;
- Have received any of the following treatments:
- Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;
- Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
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- Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
- Subjects who need to receive corticosteroids (equivalent to\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;
- Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;
- Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
- The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/exclusion criteria;
- Patients with active central nervous system metastases;
- Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma/allergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
- Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies/mL);
- The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;
- Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0\>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics;
- History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
- Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
- Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate\>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;
- Pregnant or lactating women;
- According to the researcher\'s assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject\'s safety or the collection of trial data.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Xianglin Yuan, +8613986296106, yxl@medmail.com.cn
About this study
Official title: Prospective, Dual Arm, Open Ib/II Phase Clinical Study of the Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer
This study is a prospective, dual arm, open Ib/II phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer.
The study is divided into two stages. The first stage is the safety introduction period, which includes 6 patients. Observe whether the subjects experience dose limiting toxicity (DLT) during the observation period. If no subjects experience DLT during the observation period, the study enters the next stage. The dose of Lrinotecan liposome used during the safety introduction period is 80mg/m2, and the DLTs observation period is 1 cycle. If the patient cannot tolerate it, the dose will be reduced to 60mg/m2.
Read more
In the second stage, advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts: those who have previously received immune checkpoint inhibitor therapy and have first-line PFS\>7m (cohort 1) and those who have received standard systemic chemotherapy (cohort 2). 30 subjects will be included in each population, and a total of 66 subjects are planned to be enrolled.
The study includes a screening period (from the signing of the informed consent form by the subjects to the first treatment, not exceeding 28 days), a treatment period (Adebrelimab combined with Apatinib and Lrinotecan liposome), and a follow-up period (including safety and survival follow-up).
- Conditions
- Advanced Gastric Cancer
- Being tested
- Adebrelimab + Apatinib + Lrinotecan liposome
- Keywords
- Second line advanced gastric cancer, Lrinotecan liposome, Immune checkpoint inhibitors, Anti-L1 antibody, apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + Apatinib + Lrinotecan liposomeDrug
Adebrelimab 1200 mg, iv. q3w
Apatinib 250 mg po qd
Lrinotecan liposome 80mg/m2, iv. q3w
Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Frontline has received treatment with immune checkpoint inhibitors | Experimental | Previously received first-line treatment with immune checkpoint inhibitors, and first-line PFS>7m
Adebrelimab 1200 mg, iv. q3w
Apatinib 250 mg po qd
Lrinotecan liposome 80mg/m2, iv. q3w
Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. Receives: Drug: Adebrelimab + Apatinib + Lrinotecan liposome |
| Previously not received immune checkpoint inhibitor treatment | Experimental | those who have received standard systemic chemotherapy
Adebrelimab 1200 mg, iv. q3w
Apatinib 250 mg po qd
Lrinotecan liposome 80mg/m2, iv. q3w
Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. Receives: Drug: Adebrelimab + Apatinib + Lrinotecan liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival（PFS）
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (4)
Median overall survival (mOS)
Measured: From date of randomization until date of death from any cause, assessed up to 12 months
Objective response rate (ORR)
Measured: From enrollment to initial efficacy evaluation，Expected to be evaluated in about 2 months
Disease Control Rate（DCR）
Measured: From enrollment to initial efficacy evaluation，Expected to be evaluated in about 2 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From enrollment to 90 days after the last medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xianglin Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592287
- Sponsor's protocol ID
- MA-GC-II-016
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Dual Arm, Open Ib/II Phase Clinical Study of the Combination of Adebrelimab, Apatinib, and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06592287
- Acronym / sponsor ID
- MA-GC-II-016
- Conditions
- Advanced Gastric Cancer
- Keywords
- Second line advanced gastric cancer, Lrinotecan liposome, Immune checkpoint inhibitors, Anti-L1 antibody, apatinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Xianglin YuanUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Sep 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 study is a prospective, dual arm, open Ib/II phase clinical trial, with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer.
The study is divided into two stages. The first stage is the safety introduction period, which includes 6 patients. Observe whether the subjects experience dose limiting toxicity (DLT) during the observation period. If no subjects experience DLT during the observation period, the study enters the next stage. The dose of Lrinotecan liposome used during the safety introduction period is 80mg/m2, and the DLTs observation period is 1 cycle. If the patient cannot tolerate it, the dose will be reduced to 60mg/m2.
In the second stage, advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts: those who have previously received immune checkpoint inhibitor therapy and have first-line PFS\>7m (cohort 1) and those who have received standard systemic chemotherapy (cohort 2). 30 subjects will be included in each population, and a total of 66 subjects are planned to be enrolled.
The study includes a screening period (from the signing of the informed consent form by the subjects to the first treatment, not exceeding 28 days), a treatment period (Adebrelimab combined with Apatinib and Lrinotecan liposome), and a follow-up period (including safety and survival follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frontline has received treatment with immune checkpoint inhibitors | Experimental | Drug: Adebrelimab + Apatinib + Lrinotecan liposomePreviously received first-line treatment with immune checkpoint inhibitors, and first-line PFS>7m Adebrelimab 1200 mg, iv. q3w Apatinib 250 mg po qd Lrinotecan liposome 80mg/m2, iv. q3w Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. |
| Previously not received immune checkpoint inhibitor treatment | Experimental | Drug: Adebrelimab + Apatinib + Lrinotecan liposomethose who have received standard systemic chemotherapy Adebrelimab 1200 mg, iv. q3w Apatinib 250 mg po qd Lrinotecan liposome 80mg/m2, iv. q3w Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age range: 18 to 75 years old, both male and female are acceptable;
- Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- Patients who have only received one failed systemic treatment for advanced diseases in the past; After undergoing immunotherapy, the PFS of the treatment regimen containing immune checkpoint inhibitors must be greater than 7 months;
- According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);
- ECOG score: 0-1 point;
Key exclusion criteria (21 listed)
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
- There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
- Have a history of allergies to any component of Adebrelimab in the past;
- Have received any of the following treatments:
- The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/exclusion criteria;
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 |
|---|---|---|
| Adebrelimab + Apatinib + Lrinotecan liposomeAdebrelimab 1200 mg, iv. q3w Apatinib 250 mg po qd Lrinotecan liposome 80mg/m2, iv. q3w Continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. | Drug | Frontline has received treatment with immune checkpoint inhibitors, Previously not received immune checkpoint inhibitor treatment |
Primary outcome
Progress Free Survival（PFS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
4 secondary outcomes
Median overall survival (mOS)
Time frame: From date of randomization until date of death from any cause, assessed up to 12 months
Objective response rate (ORR)
Time frame: From enrollment to initial efficacy evaluation，Expected to be evaluated in about 2 months
Disease Control Rate（DCR）
Time frame: From enrollment to initial efficacy evaluation，Expected to be evaluated in about 2 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From enrollment to 90 days after the last medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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 Adebrelimab + Apatinib + Lrinotecan liposome in people with Advanced Gastric Cancer, run by Xianglin Yuan 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 10 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 19 Sep 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 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 Xiang lin Yuan (+86 13986296106, yxl@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival（PFS） (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months). 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 19 Sep 2024.