Trial Title:
A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.
NCT ID:
NCT06136988
Condition:
Locally Advanced Unresectable Esophageal Squamous Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Paclitaxel
Docetaxel
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel for Injection (Albumin-bound)
Description:
Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m^2, Intravenous infusion, Q3W
Arm group label:
HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy
Other name:
HB1801
Intervention type:
Drug
Intervention name:
SG001
Description:
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous
infusion, Q3W
Arm group label:
HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy
Other name:
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection
Intervention type:
Drug
Intervention name:
Cisplatin for injection
Description:
Cisplatin for injection, 25 mg/m^2, Intravenous infusion, D1-D3, Q3W
Arm group label:
HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy
Arm group label:
Paclitaxel in combination with cisplatin and simultaneous radiotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 135 mg/m^2, Intravenous infusion, Q3W
Arm group label:
Paclitaxel in combination with cisplatin and simultaneous radiotherapy
Intervention type:
Radiation
Intervention name:
Simultaneous Radiotherapy
Description:
Radiotherapy (28×1.8Gy)
Arm group label:
HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy
Arm group label:
Paclitaxel in combination with cisplatin and simultaneous radiotherapy
Summary:
The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and
safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with
cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin
and simultaneous radiotherapy for locally advanced unresectable esophageal squamous
carcinoma.
Detailed description:
This study will be conducted in two stages. The first stage (Phase Ib) is a
dose-escalation study designed to determine the safety and the recommended Phase 2 dose
(RP2D) of HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy
for locally advanced unresectable esophageal squamous carcinoma. Patients will be
assigned to receive sequentially higher doses of HB1801 once every three weeks (a Cycle)
by intravenous infusion, starting at a dose of 60 mg/m^2. The second stage (Phase II) is
a study to evaluate the efficacy and safety of HB1801 and SG001 in combination with
cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin
and simultaneous radiotherapy for locally advanced unresectable esophageal squamous
carcinoma. Regular visits and imaging examinations will be conducted to compare the
efficacy and safety of the two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years (based on the day of signing the informed consent form).
2. Voluntarily sign the informed consent, willing and able to follow the protocol for
visits, treatment and laboratory tests.
3. Locally advanced (stage II-IVa and IVb supraclavicular lymph node metastases
according to AJCC 8th edition) esophageal squamous carcinoma (in the case of mixed
adenosquamous carcinoma, more than 50% squamous carcinoma component can be screened)
diagnosed histologically or cytologically, which is unresectable in the judgment of
the principal investigator, and is amenable to definitive chemoradiotherapy (dCRT) .
4. ECOG score of 0-1 within 7 days prior to the first dose.
5. Vital organ function within 7 days prior to first dose, meeting the following
criteria (no blood transfusions, no use of human granulocyte colony-stimulating
factor (G-CSF), thrombopoietin (TPO), and erythropoietin (EPO) within 14 days prior
to the first dose):
1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
2. Platelet count (PLT) ≥ 100×10^9/L
3. Hemoglobin ≥ 80g/L
4. Serum albumin ≥ 28g/L
5. Total bilirubin ≤1.0×ULN; ALT/AST ≤1.5×ULN
6. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min, Cockcroft-Gault
formula
7. Activated Prothrombin Time (APTT) and International Normalized Ratio (INR) ≤
1.5 x ULN.
6. Female patients of childbearing age tested negative serum pregnancy test within 7
days prior to the first dose, and patients must agree to take effective
contraception from the signing of the informed consent form until 6 months after the
last dose, during which time breastfeeding is not allowed; male patients must agree
to take contraception and sperm donation is not allowed.
7. Have at least one evaluable lesion per Response Evaluation Criteria In Solid Tumors
(RECIST 1.1).
Exclusion Criteria:
1. Active malignancy within 5 years prior to the first dose, except esophageal
carcinoma studied in this trial and any locally curable tumor that has received
radical therapy (e.g., resected basal or squamous cell skin cancer, superficial
bladder cancer, carcinoma in situ of the cervix or breast, or early-stage thyroid
cancer, etc).
2. History of esophageal perforation and/or esophageal fistula within 6 months prior to
the first dose; or significant tumor invasion into an organ adjacent to the
esophageal lesion (aorta or trachea), etc., resulting in a high risk of hemorrhage,
esophageal fistula, or signs of esophageal perforation.
3. Uncontrollable plasma effusions requiring frequent drainage or medical intervention
(e.g., pleural effusion, peritoneal effusion, pericardial effusion, etc.) within 7
days prior to the first dose that require additional interventions within 2 weeks of
the intervention (excluding exfoliative cytology of the exudate).
4. Weight loss of 20% or more within 3 months prior to the first dose; or BMI <18.5
kg/m^2 and/or weight <30 kg.
5. Severe allergy history to albumin or docetaxel, paclitaxel, cisplatin, or monoclonal
antibody drugs.
6. Patients who have received prior antitumor therapy for esophageal cancer.
7. Patients with immunodeficiency or active autoimmune disease (except a.
well-controlled type I diabetes b. hypothyroidism [controlled with hormone
replacement therapy] c. well-controlled celiac disease d. dermatologic that do not
require systemic therapy [e.g., vitiligo, psoriasis, alopecia] e. any other
condition not expected to recur in the absence of external triggers).
8. History of severe cardiovascular disease within 6 months prior to the first dose,
including but not limited to:
1. Severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmias requiring clinical intervention, Third-degree atrioventricular
block
2. History of myocardial infarction, unstable angina, angioplasty, coronary artery
bridging surgery
3. Heart failure with New York Heart Association (NYHA) classification of class
III and above
4. Left ventricular ejection fraction (LVEF) <50% at screening period
5. Patients with prolonged QT/QTc interval on ECG at baseline (QTcF > 480ms,
Fridericia formula: QTcF=QT/RR^0.33, RR=60/heart rate).
9. Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg
and/or diastolic blood pressure ≥100 mmHg during the screening period).
10. Patients with active Hepatitis B (Hepatitis B surface antigen (HBsAg) or HBcAb
positive test and active stage of Hepatitis B (HBV-DNA ≥ 10^4 cps/mL or ≥ 2000
IU/mL)); Hepatitis C (Hepatitis C Antibody (Anti-HCV) positive test and a positive
PCR result for HCV RNA); positive for HIV, during the screening period.
11. Patients with poorly controlled diabetes mellitus, or hypokalemia, hyponatremia, or
abnormal values on corrected calcium lab tests (CTCAE 5.0 >1 grade) despite of
standard drug therapy within 14 days prior to the first dose.
12. History of interstitial lung disease or non-infectious pneumonia.
13. Patients with known psychoneurologic disorders that may affect adherence to the
trial, and those with a history of drug dependence;
14. Patients with severe chronic or active infections (including tuberculosis infection,
etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14
days prior to the first dose. Note: Antiviral therapy for patients with viral
hepatitis is permitted.
15. Have received potent inhibitors or potent inducers of CYP2C8 (for Phase Ⅱ trials
only) or CYP3A4 within 14 days prior to the first dose.
16. Vaccination with a live or live attenuated vaccine (inactivated vaccines are
permitted) within 28 days prior to the first dose.
17. History of major organ surgery (excluding puncture biopsy) within 28 days prior to
the first dose.
18. Patients who have received antitumor therapy such as other clinical investigational
drugs within 28 days prior to the first dose.
19. Patients who have received systemic glucocorticoid therapy (dose > 10 mg/day of
prednisone or equivalent) within 28 days prior to the first dose.
20. Any condition that, in the opinion of the investigator, makes participation in the
study inappropriate (including, but not limited to, concurrent serious or
uncontrolled medical conditions, potential safety risks, interference with the
interpretation of the results of the study, and adherence to the trial).
21. The patient is concurrently participating in another clinical study, unless it is an
observational (non-interventional) clinical study or is in the follow-up period of
an interventional study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Tumor Hospital
Address:
City:
Jinan
Country:
China
Contact:
Last name:
Jin ming Yu
Phone:
86-531-67627156
Email:
sdyujinming@126.com
Facility:
Name:
Tianjin cancer institute &hospital
Address:
City:
Tianjin
Country:
China
Contact:
Last name:
Qing song Pang
Phone:
86-18622221203
Email:
pangqingsong2016@163.com
Start date:
December 2023
Completion date:
April 2028
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136988
