Trial Title:
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
NCT ID:
NCT06472037
Condition:
Locally Advanced Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
10mg/kg，IV，D1，Q3W
Arm group label:
Gemcitabine and Nab-palitaxe combined with Cadonilimab
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000mg/m2，IV，D1、D8、D15，Q4W
Arm group label:
Gemcitabine and Nab-palitaxe combined with Cadonilimab
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
125mg/m2，IV，D1、D8、D15，Q4W
Arm group label:
Gemcitabine and Nab-palitaxe combined with Cadonilimab
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients eligible for this study must meet all of the following criteria:
1. Obtain written informed consent before implementing any trial-related procedures;
2. Age ≥ 18 years and ≤ 75 years, gender not specified;
3. Pancreatic cancer confirmed by histopathology examination;
4. Locally advanced pancreatic ductal adenocarcinoma and no prior anti-tumor treatment
(radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received;
5. At least one measurable lesion on imaging according to Response Evaluation Criteria
in Solid Tumors (RECIST 1.1).
6. ECOG score 0-1;
7. Expected survival time >3 months;
8. Adequate organ function, subjects must meet the following laboratory criteria:
1)Absolute neutrophil count (ANC) ≥1.5x10^9/L without the use of granulocyte
colony-stimulating factor in the past 14 days.
2)Platelet count ≥100x10^9/L without blood transfusion in the past 14 days. 3)Hemoglobin
> 9g/dL without blood transfusion or use of erythropoietin in the past 14 days; 4)Total
bilirubin ≤ 1.5 times the upper limit of normal (ULN); 5)Aspartate aminotransferase (AST)
and alanine aminotransferase (ALT) ≤ 2.5 times ULN; 6)Serum creatinine ≤ 1.5 times ULN
and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60ml/min;
7)Good coagulation function, defined as international normalized ratio (INR) or
prothrombin time (PT) ≤ 1.5 times ULN; 8)Normal thyroid function is defined as
thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside
the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may
also be included in the study.
9.For female subjects of childbearing potential, a urine or serum pregnancy test should
be performed within 3 days before receiving the first dose of the study drug (Day 1 of
Cycle 1) and the result should be negative. If the urine pregnancy test result cannot be
confirmed as negative, a blood pregnancy test is required. Non-childbearing potential
female subjects are defined as postmenopausal for at least 1 year, or having undergone
surgical sterilization or hysterectomy.
10.All subjects, male or female, were required to use contraception with an annual
failure rate of less than 1% during the entire treatment period up to 120 days after the
last dose of study drug (or 180 days after the last dose of chemotherapeutic drug) if
there was a risk of pregnancy.
Exclusion Criteria:
1. 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);
2. 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;
3. 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);
4. 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;
5. 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;
6. 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;
7. Known allogeneic organ transplantation (except corneal transplantation) or
allogeneic hematopoietic stem cell transplantation;
8. Known allergy to the investigational drug carfilzomib, gemcitabine, or any excipient
of albumin-bound paclitaxel;
9. 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);
10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1/2
antibody positive);
11. Uncontrolled active hepatitis B (defined as HBsAg positive with detectable HBV-DNA
copies above the upper limit of normal for the testing laboratory at the study
center);
Note: Subjects with the following criteria can also be included:
1. HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, subjects should
receive anti-HBV treatment throughout the study drug treatment period to prevent
viral reactivation
2. Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not
need to receive prophylactic anti-HBV treatment, but need close monitoring for viral
reactivation 12.Subjects with active HCV infection (HCV antibody positive and
HCV-RNA levels above the detection limit); 13.Received live vaccines within 30 days
before the first dose (Cycle 1, Day 1); Note: Administration of inactivated
influenza vaccine for seasonal flu is allowed within 30 days before the first dose,
but intranasal live attenuated influenza vaccine is not allowed.
14.Pregnant or lactating women; 15.Presence of any severe or uncontrolled systemic
diseases, such as:
1. Resting electrocardiogram showing significant and symptomatic abnormalities in
rhythm, conduction, or morphology, such as complete left bundle branch block,
second-degree or higher heart block, ventricular arrhythmias, or atrial
fibrillation;
2. Unstable angina, congestive heart failure, chronic heart failure with New York Heart
Association (NYHA) class ≥2;
3. Any arterial thrombosis, embolism, or ischemia events such as myocardial infarction,
unstable angina, cerebrovascular accident, or transient ischemic attack within 6
months prior to initiation of therapy;
4. Suboptimal blood pressure control (systolic blood pressure >140mmHg, diastolic blood
pressure >90mmHg);
5. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year
prior to initial dosing, or current clinical active interstitial lung disease;
6. Active pulmonary tuberculosis;
7. Active or uncontrolled infections requiring systemic therapy.
8. Clinical active diverticulitis, intra-abdominal abscess, gastrointestinal
obstruction;
9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic
active hepatitis;
10. Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L);
11. Urinalysis shows urine protein ≥++, and confirmed 24-hour urine protein
quantification >1.0g;
12. Presence of mental disorders and inability to cooperate with treatment; 16 There may
be potential risks that could interfere with the trial results, hinder the full
participation of subjects in the study, such as medical history or evidence of
diseases, abnormal treatment or laboratory test values, or other conditions deemed
unsuitable for inclusion by the researchers. Researchers may also identify other
potential risks that make participation in this study unsuitable.
Gender:
All
Minimum age:
17 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Start date:
July 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06472037
