NCT06472037
Recruiting
Phase 2
A Prospective, Single-arm, Phase II Study Assessing the Efficacy of Gemcitabine, Nab-paclitaxel, and Cadonilimab With Sequential Short-course Radiotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma Patients.
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country30 target enrollmentJuly 1, 2024
Overview
- Phase
- Phase 2
- Intervention
- Cadonilimab
- Conditions
- Locally Advanced Pancreatic Ductal Adenocarcinoma
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Clinical benefit rate (CBR, CR+PR+SD)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.
Detailed Description
This trial is a prospective, single-arm, single-center, phase II clinical study aimed at investigating the efficacy and safety of Cadonilimab combined with Gemcitabine and Nab-palitaxe in short-course radiotherapy neoadjuvant treatment for locally advanced pancreatic ductal adenocarcinoma patients. Patients will receive Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment for one cycle, followed by sequential short-course radiotherapy and then Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment. If feasible, radical surgery will be performed to assess efficacy. A total of 8 cycles of chemotherapy will be administered, followed by Cadonilimab maintenance for up to 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients eligible for this study must meet all of the following criteria:
- •Obtain written informed consent before implementing any trial-related procedures;
- •Age ≥ 18 years and ≤ 75 years, gender not specified;
- •Pancreatic cancer confirmed by histopathology examination;
- •Locally advanced pancreatic ductal adenocarcinoma and no prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received;
- •At least one measurable lesion on imaging according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- •ECOG score 0-1;
- •Expected survival time \>3 months;
- •Adequate organ function, subjects must meet the following laboratory criteria:
- •Absolute neutrophil count (ANC) ≥1.5x10\^9/L without the use of granulocyte colony-stimulating factor in the past 14 days.
Exclusion Criteria
- •Malignant diseases other than pancreatic cancer diagnosed within 5 years before the first administration (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection);
- •Is currently participating in an interventional clinical study or has received other study medication or used the study device within 4 weeks prior to the first dose;
- •Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs directed against another stimulatory or synergistic T cell receptor suppressor (e.g., CTLA-4, OX-40, CD137);
- •Systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control ascites) within 2 weeks before the first administration;
- •Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy;
- •Is receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal, inhaled, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: The use of physiological doses of glucocorticoids (≤10mg/day of prednisone or equivalent) is allowed;
- •Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- •Known allergy to the investigational drug carfilzomib, gemcitabine, or any excipient of albumin-bound paclitaxel;
- •Have not fully recovered from any toxicities and/or complications due to any prior interventions before starting treatment (i.e., ≤ Grade 1 or back to baseline, excluding fatigue or alopecia);
- •Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2 antibody positive);
Arms & Interventions
Gemcitabine and Nab-paclitaxel combined with Cadonilimab and Sequential Short-course Radiotherapy
Cadonilimab 10mg/kg Q3W；Gemcitabine 1000mg/m2 Q4W；Nab-paclitaxel 125mg/m2 Q4W； Short-course Radiotherapy
Intervention: Cadonilimab
Gemcitabine and Nab-paclitaxel combined with Cadonilimab and Sequential Short-course Radiotherapy
Cadonilimab 10mg/kg Q3W；Gemcitabine 1000mg/m2 Q4W；Nab-paclitaxel 125mg/m2 Q4W； Short-course Radiotherapy
Intervention: Gemcitabine
Gemcitabine and Nab-paclitaxel combined with Cadonilimab and Sequential Short-course Radiotherapy
Cadonilimab 10mg/kg Q3W；Gemcitabine 1000mg/m2 Q4W；Nab-paclitaxel 125mg/m2 Q4W； Short-course Radiotherapy
Intervention: Nab-Paclitaxel
Outcomes
Primary Outcomes
Clinical benefit rate (CBR, CR+PR+SD)
Time Frame: 1 year
Clinical benefit rate ( complete response and partial response and stable disease)
Secondary Outcomes
- Surgical conversion rate(1 year)
- ORR(1 yaear)
- PCR(1 year)
- (EFS)RECIST 1.1(1 year)
- OS(1 year)
- (AEs)CTCAE 5.0(1 year)
Study Sites (1)
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