Status and phase
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About
This study aims to assess the efficacy and safety of a combination therapy consisting of Anlotinib, TQB2450 (a PD-L1 inhibitor), and Albumin-bound Paclitaxel regimens in patients with advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who have failed the previous treatment with Claudin18.2 (CLDN18.2)-related regimens.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Voluntarily join this study, sign the informed consent form, and have good compliance;
Pathologically (histologically or cytologically) confirmed HER2/neu-negative (or HER2/neu status unclear) advanced gastric cancer or gastroesophageal junction adenocarcinoma;
Patients who have failed first-line treatment with CLDN18.2-related regimen (CLDN18.2 drugs include CLDN18.2 monotherapy, CLDN18.2 dual therapy, CLDN18.2 ADC or CLDN18.2 CART therapy, treatment regimen includes CLDN18.2 combined with chemotherapy or immunotherapy or other systemic therapy) and the time from the end of the last treatment with CLDN18.2-related drugs is more than two weeks;
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one measurable lesion, which can be accurately measured in at least one direction (the maximum diameter needs to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), with the longest diameter at baseline ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm); the measurable lesions should not have received local treatment such as radiotherapy (lesions in the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions);
Male or female patients aged ≥18 years and ≤75 years;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-1;
Expected survival ≥3 months;
Adequate organ function, requiring the following laboratory test values at screening:
Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and must be non-lactating patients. Serum or urine pregnancy test negative within 7 days before enrollment in the study, or meet one of the following criteria to prove that there is no risk of pregnancy:
Exclusion criteria
For cohort 1, patients who have previously received anlotinib hydrochloride treatment or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll; For cohort 2 and cohort 3, patients who have received PD-L1 immune checkpoint inhibitor treatment in the first line are excluded, but patients who have received PD-1 or CTLA-4 immune checkpoint inhibitor treatment in the first line are allowed, if they have any of the following immune-related medical history and treatment history, they are excluded:
For Cohort 3, patients who have previously received anlotinib hydrochloride or other anti-angiogenic small molecule tyrosine kinase inhibitors (TKIs) within 6 months. Patients who have stopped treatment with other anti-angiogenic small molecule TKIs for more than 6 months are allowed to enroll;
Patients who have received anti-tumor treatment with traditional Chinese medicine within the past two weeks (the traditional Chinese medicine contains the following medicinal materials such as Brucea javanica, Coix seed, Lentinan, Cantharidin, Toad skin, Astragalus, Sophora, Ugonin, Chebula, Icariin, etc.), but patients who have stopped taking anti-tumor treatment with traditional Chinese medicine for more than two weeks are allowed to enroll;
Patients who have received ≥1 other systemic systemic anti-tumor treatment (including but not limited to chemotherapy, immunotherapy, targeted therapy, and other systemic treatment regimens) after failing CLDN18.2-related regimen treatment, but palliative local treatment (including radiotherapy and other local treatment regimens) for local lesions (non-target lesions) >two weeks later are allowed to enroll;
Patients who have previously received allogeneic bone marrow transplantation or organ transplantation;
Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia;
Patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with a history of central nervous system metastases or spinal cord compression, if they have received treatment and stopped using anticonvulsants and steroids 4 weeks before the first administration of the study and have clinically stable performance, can enroll in the study;
≥ NCI CTCAE grade 2 peripheral neuropathy;
Infection requiring antibiotics within 14 days before the start of the trial;
Patients with bone metastases at risk of paraplegia;
Patients with any severe and/uncontrolled disease, including:
Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the study, or expected to need major surgery during the study treatment, or non-diagnostic surgery within 4 weeks before the start of the trial;
History of gastrointestinal perforation and/or fistula within 6 months before enrollment; or history of arterial/venous thromboembolic events, such as cerebrovascular accident (stable cerebral infarction excluded by researcher evaluation), deep vein thrombosis, and pulmonary embolism;
Clinically significant pleural effusion, including any pleural effusion that can be found by physical examination, pleural effusion that has been treated in the past or still needs treatment. Patients with only a small amount of pleural effusion shown by imaging but no symptoms, and who do not need treatment according to the researcher's evaluation, can be enrolled;
Body mass index (BMI) <17.0 kg/m² or weight loss of ≥10% within 2 months before screening;
Patients with a history of psychotropic drug abuse and unable to quit or have mental disorders;
Patients with active hepatitis B or hepatitis C, HIV-positive patients, patients with active tuberculosis;
CT suggests definite ulcerative lesions, or occult blood in stool ++ or above;
History of abnormal bleeding (except epistaxis) within 1 month before enrollment;
History of other primary malignant tumors, except for the following: 1) Malignant tumors that have been completely remitted for at least 2 years before enrollment and do not require other treatment during the study; 2) Non-melanoma skin cancer or malignant melanocytic nevus that have been adequately treated and have no evidence of disease recurrence; 3) In situ carcinoma that has been adequately treated and has no evidence of disease recurrence;
Pregnant or lactating female patients;
According to the researcher's judgment, patients with severe accompanying diseases that endanger the patient's safety or affect the patient's completion of the study;
Participated in other trials within 30 days before the start of the trial, or plan to participate in other trials during the trial.
Primary purpose
Allocation
Interventional model
Masking
90 participants in 1 patient group
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Central trial contact
Lin Shen; Yakun Wang
Data sourced from clinicaltrials.gov
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