Trial Title:
Neoadjuvant Treatment of Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05947201
Condition:
The Efficacy and Safety of Therapy Efficacy for Locally Advanced ESCC
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Fluorouracil
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants
in this study will be given intravenous administration of AK104 (10 mg/kg d1) combined
with cisplatin (20 mg/m2 on d1-3) and albumin paclitaxel (100mg/m2 on d1, d8),
fluorouracil (600 mg/m2 on d1-5) every three weeks for a cycle of treatment, which will
be conducted two or three cycles, and radical surgery within 4-6 weeks after the last
administration. Treatments will be administrated until disease progression, unacceptable
adverse events (AE), concomitant diseases that hinder continued treatment.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab Combined Albumin-paclitaxel, Cisplatin and Fluorouracil
Description:
If the addition of Cadonilimab to neoadjuvant chemotherapy further improve the efficiency
for locally advanced esophageal squamous cell carcinoma
Arm group label:
AK104+cisplatin+albumin paclitaxel+fluorouracil
Other name:
rutine
Summary:
This is a single-arm clinical study to evaluate the efficacy and safety of Cadonilimab in
combination with preoperative chemotherapy for locally advanced esophageal squamous cell
carcinoma Locally Advanced Esophageal Squamous Cell Carcinoma
Detailed description:
Esophageal cancer is the eighth most lethal tumor and the sixth leading cause of
cancer-related deaths worldwide. Esophageal squamous cell carcinoma accounts for up to
95% of the pathological types and threatens the health of chinese residents. Investigator
designed a single-arm, open-label, phase II trial and the purpose of this study is to
observe and evaluate the efficacy and safety of Cadonilimab combined with preoperative
chemotherapy for locally advanced esophageal squamous cell carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants who have given their consent and signed an informed consent form, are
willing and able to comply with the study visits, treatment, laboratory tests, and
other trial procedures.
2. Patients with a pathological diagnosis of (thoracic) esophageal squamous cell
carcinoma.
3. Age between 18 and 75 years (inclusive), both male and female.
4. Locally advanced esophageal squamous cell carcinoma without suspicious cervical
lymph node metastasis and distant metastasis (cT1N1-3M0 or cT2-3N0-3M0, AJCC 8th
edition).
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. No prior systemic treatment for esophageal cancer (including chemotherapy, targeted
therapy, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies,
anti-CTLA-4 antibodies, etc.).
7. Planned surgical treatment after completion of neoadjuvant therapy.
8. Expected survival time of at least 6 months.
9. Clearly measurable lesions that meet the Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.1.
10. Adequate organ function based on laboratory values obtained during the screening
period, including:
1) Hematology: no blood transfusions or blood products within 14 days, no use of G-CSF
or other hematopoietic growth factors for correction, white blood cell count (WBC) ≥
3.0 × 109/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥
75 × 109/L, hemoglobin (Hgb) ≥ 9 g/dL.
2) Blood chemistry: serum total bilirubin ≤ 1.5 × upper limit of normal (ULN),
aspartate aminotransferase or alanine aminotransferase ≤ 2.5 × ULN (≤ 5 × ULN for
patients with liver metastasis), serum creatinine ≤ 1.5 × ULN.
3) Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤
1.5 × ULN.
4) Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%. 11. Female
participants of childbearing potential must have a negative serum pregnancy test
within 3 days before starting study drug and agree to use a medically accepted
highly effective method of contraception (such as an intrauterine device,
contraceptive pills, or condoms) during the study period and within 3 months after
the last dose of study drug. Male participants with partners of childbearing
potential must have undergone surgical sterilization or agree to use an effective
method of contraception during the study period and within 3 months after the last
dose of study drug.
Exclusion Criteria:
1. History of or concurrent active malignancy other than adequately treated
non-melanoma skin cancer, curatively treated in situ cancer or other malignancy with
no evidence of disease for at least 5 years.
2. Active bleeding within 3 months; a history of arterial or venous thrombotic events
within 6 months, such as stroke (including transient ischemic attack), deep vein
thrombosis, and pulmonary embolism; known inherited or acquired bleeding diathesis
(e.g., coagulation factor deficiencies) or thrombotic disorders, such as patients
with hemophilia; current or recent (within 10 days before the start of the study
treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents
for therapeutic purposes (allowed prophylactic use of low-dose aspirin and
low-molecular-weight heparin); major surgery (excluding biopsy) within 4 weeks
before starting study drug treatment or the surgical incision has not fully healed;
current or recent (within 10 days before the start of the study treatment) use of
aspirin (> 325 mg/day [maximum antiplatelet dose]) or other nonsteroidal
anti-inflammatory drugs, dual antiplatelet therapy, clopidogrel, prasugrel,
ticagrelor, or cilostazol.
3. The patient has received systemic treatment, surgery, or radiotherapy for esophageal
cancer, including immunotherapy such as anti-PD-1 or PD-L1 antibodies, anti-CTLA-4
antibodies, targeted therapy, or chemotherapy.
4. The patient has used systemic corticosteroids or other systemic immunosuppressive
drugs within 2 weeks before treatment, or is expected to use systemic
immunosuppressive drugs during the trial. The use of inhaled glucocorticoids or
physiological replacement doses of glucocorticoids is allowed.
5. The patient has active autoimmune diseases. Patients with type 1 diabetes,
hypothyroidism requiring replacement therapy only, skin diseases (such as vitiligo,
psoriasis, or alopecia) that do not require systemic treatment or are not expected
to recur without external triggering factors can be included in the trial.
6. The patient has known active tuberculosis, is receiving anti-tuberculosis treatment,
or has received anti-tuberculosis treatment within 1 year prior to the first dose.
7. The patient has severe, uncontrolled systemic diseases, such as refractory
hypertension, severe active infection, etc.
8. The patient has known human immunodeficiency virus (HIV) infection or is known to be
HIV-seropositive.
9. Untreated chronic hepatitis B or active carriers of hepatitis B virus (HBV) (HBV DNA
>500 IU/mL) or active carriers of HCV detectable by HCV RNA. Note: Inactive carriers
of hepatitis B surface antigen (HBsAg) or stable patients with treated chronic
hepatitis B (HBV DNA < 500 IU/mL) can be included in the study.
10. History of interstitial lung disease, drug-induced interstitial lung disease,
radiation pneumonitis, or symptomatic interstitial lung disease, or active pneumonia
detected by chest CT scan within 4 weeks prior to initial drug treatment in the
study.
11. Known symptomatic, untreated, or progressively advancing central nervous system
(CNS) or leptomeningeal metastases.
12. Known allergy to any investigational drug or excipient.
13. Participation in other drug clinical trials within 4 weeks before enrollment.
14. Breastfeeding women.
15. As judged by the investigator, the patient has other factors that may affect the
study results or may cause premature termination of the study, such as alcoholism,
drug abuse, other serious illnesses (including mental illness) requiring concomitant
treatment, significant laboratory abnormalities, or family or social factors that
may affect the patient's safety.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Lulu Liu
Address:
City:
Hanzhou
Zip:
0571
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu lu Liu, M.D.
Phone:
0571-87237587
Email:
liululu2001@zju.edu.cn
Start date:
May 8, 2023
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Weijia Fang, MD
Agency class:
Other
Collaborator:
Agency:
Akeso Pharmaceuticals, Inc.
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05947201
