NCT06118645
Not yet recruiting
Phase 2
An Open, Multicenter, Phase II Study of Cadonilimab Combined With Paclitaxel (Albumin-bound) in the Treatment of Advanced Gastric Adenocarcinoma or Esophagogastric Junction Adenocarcinoma With PD-(L)1 Inhibitors Resistance
ConditionsGastric Adenocarcinoma
Interventionscadonilimab combined +paclitaxel (albumin-bound)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 40
- Primary Endpoint
- 6-month progression-free survival assessed by RECIST v1.1
Overview
Brief Summary
Cadonilimab combined with paclitaxel (albumin-bound) treat advanced gastric adenocarcinoma or esophagogastric junction adenocarcinoma with PD-(L)1 inhibitors resistance
Detailed Description
An open, multicenter, Phase II study of cadonilimab combined with paclitaxel (albumin-bound) in the treatment of advanced gastric adenocarcinoma or esophagogastric junction adenocarcinoma that has failed prior treatment with PD-(L)1 inhibitors
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be able to understand and voluntarily sign a written informed consent, which must be signed prior to performing the specified study procedure required for the study.
- •Age and gender: ≥18 years old and≤75 years old, both men and women.
- •The Eastern United States Cancer Collaborative (ECOG) physical Fitness score was 0-
- •Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma or esophagogastric junction adenocarcinoma (EGJ defined as the center of the tumor within 5 cm of the anatomic location of the cardia, as described in the Siewert classification system).
- •Patients who have progressed or become intolerant after prior treatment with a regimen containing PD-1/PD-L1 monoclonal antibody had a tumor shrinkage response assessed as CR, PR, or reduced SD(\<0% reduction in total target lesion diameter from baseline according to RECIST v 1.1) and persisted for 4 months or more after treatment with PD-1/PD-L1 monoclonal antibody If the disease progresses during neoadjuvant/adjuvant chemotherapy or radical chemoradiotherapy or within 6 months after the end of the last treatment, it is considered to have received first-line treatment
- •Expected survival ≥12 weeks.
- •According to RECIST v1.1, subjects must have at least one measurable lesion. For subjects who have previously received radiotherapy, a radiation-treated lesion may be considered a target if there is objective evidence of significant progression after radiotherapy if there is no other alternative target lesion.
- •Subjects are required to provide the most recent archived (at least 2 years old) and/or freshly obtained tumor tissue samples and at least 3 unstained FFPE pathological slides.
- •The functions of important organs must meet the following requirements:
- •(1) Hematological system: Neutrophil count≥1.5×10\^9/L; Platelet count≥100×10\^9/L; Hemoglobin≥90g/L; (2) Liver function： Serum albumin≥28g/L; Total bilirubin (TBI)≤1.5×ULN; Alanine aminotransferase (ALT)≤3×ULN (or≤5×ULN if liver metastates are present); Aspartate aminotransferase (AST)≤2.5×ULN (or≤5×ULN if liver metastates are present); (3) Renal function: Calculated creatinine clearance≥50 mL/min (using the Cockcroft-Gault formula); Female: CrCl = (140- age in years) × weight in kg × 0.85 72 × serum creatinine in mg/ dL
Exclusion Criteria
- •Patients with any of the following criteria were excluded from the study
- •Other pathological types confirmed by histopathological or cytological examination, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma and Mixed pathological types will be judged according to the main components, adenocarcinoma components confirmed by the pathologist greater than 70% can be included in the group
- •Participants had other malignancies within 3 years prior to enrollment. Subjects with other malignancies that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical cancer, or carcinoma in situ of the breast, are not excluded.
- •The last systemic anti-tumor therapy, including chemotherapy and radiotherapy, immunotherapy, targeted therapy (small molecule targeted therapy is within 2 weeks before the first drug administration), and biologic therapy, was received within 3 weeks before the first drug administration; Palliative local treatment for non-target diseases and foci was performed within 2 weeks before the first administration; Received systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc.) within 2 weeks prior to initial administration; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration。
- •Previously received immunotherapy other than PD-1/PD-L1 inhibitors, including immune checkpoint inhibitors (such as anti-CTLA-4 antibodies, anti-CD47 antibodies, anti-SIRP-α antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists, and immune cell therapy Any treatment targeting the immune mechanism of tumor action.
- •Taxoids have been used in anti-tumor therapy in the past (including chemotherapy drugs such as paclitaxel and docetaxel)..
- •HER-2 overexpression (immunohistochemistry 2+ and FISH+, and immunohistochemistry 3+) did not use anti-HER-2 therapy (including trastuzumab, etc.) in previous anti-tumor therapy.
- •Any of the following has occurred during previous treatment with PD-1/PD-L1 inhibitors:
- •(1)There has been a history of grade 3 or higher irAE(excluding endosecretory system-related irAE) from PD-1/PD-L1 inhibitor therapy that resulted in permanent discontinuance of therapy, grade 2 immune-related cardiotoxicity, or any grade of neurological or ocular irAE; (2)Prior to screening in this study, subjects who were treated with prior PD-1/PD-L1 inhibitors and did not have complete remission of all adverse events or did not have remission to grade 1 were admitted to the study if their condition was stable and asymptomatic with appropriate alternative therapy; (3)Previous adverse events requiring immunosuppressant therapy other than glucocorticoids or recurrent adverse events during prior immunotherapy requiring systemic glucocorticoid therapy.
- •People with active autoimmune diseases that have required systemic treatment within the past two years (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressive agents) and replacement therapy (such as thyroxine, islet, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a systemic treatment.
Arms & Interventions
cadonilimab combined +paclitaxel (albumin-bound)
Experimental
cadonilimab combined +paclitaxel (albumin-bound)
Intervention: cadonilimab combined +paclitaxel (albumin-bound) (Drug)
Outcomes
Primary Outcomes
6-month progression-free survival assessed by RECIST v1.1
Time Frame: 6-month
6-month progression-free survival assessed by RECIST v1.1
Secondary Outcomes
- Incidence and severity of adverse events (AES)(Until the investigator determines that there is no longer a clinical benefit ， toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco)
- Objective response rate (ORR)(Until the investigator determines that there is no longer a clinical benefit ， toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco)
- disease control rate (DCR)(Until the investigator determines that there is no longer a clinical benefit ， toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco)
- duration of response (DoR)(Until the investigator determines that there is no longer a clinical benefit ， toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco)
- progression-free survival (PFS)(Until the investigator determines that there is no longer a clinical benefit ， toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco)
- overall survival (OS)(Until the investigator determines that there is no longer a clinical benefit ， toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco)
Investigators
Jingdong Zhang
Clinical Professor
China Medical University, China
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