Clinical trial for Stomach Neoplasms
Official title Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy
ClinicalTrials.gov ID: NCT07309185
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for stomach neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- 2\. Patients who have previously failed first-line treatment including systemic chemotherapy and immune checkpoint inhibitors, and have maintained...
- 3\. According to the evaluation criteria for solid tumor how well it works 1.1 (RECIST v1.1), there should be at least one measurable lesion that has...
- 4\. ECOG score: 0-1 point;
- 5\. Expected survival period ≥ 12 weeks;
You likely can't join if
- 1\. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
- 2\. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
- 3\. History of allergies to any component of Adebrelimab in the past;
- 4\. 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...
- Simultaneously enrolled in another clinical study, unless it is an observational (non treatment) clinical study or an treatment clinical study...
See the full eligibility criteria
Who can join
- 1\. Patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- 2\. Patients who have previously failed first-line treatment including systemic chemotherapy and immune checkpoint inhibitors, and have maintained first-line use of immune checkpoint inhibitors for at least 3 months;
- 3\. According to the evaluation criteria for solid tumor how well it works 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located...
- 4\. ECOG score: 0-1 point;
- 5\. Expected survival period ≥ 12 weeks;
- 6\. 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...
- 7\. Female people with fertility, as well as male people with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom)...
- 8\. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
What rules you out
- 1\. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
- 2\. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
- 3\. History of allergies to any component of Adebrelimab in the past;
- 4\. 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 treatment) clinical study or an treatment clinical study follow-up;
- 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...
- people 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...
- 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;
- Patients who have received previous treatment with paclitaxel drugs;
- 5\. 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;
- 6\. Patients with active central nervous system metastases;
- 7\. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not...
- 8\. 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...
- 9\. 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...
- 10\. 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...
- 11\. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
- 12\. 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...
- 13\. 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...
- 14\. Pregnant or lactating women;
- 15\. 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.