- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06136988
A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.
November 16, 2023 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Multicenter, Open-label, Phase Ib/II Study of Docetaxel for Injection (Albumin-bound) 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.
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.
Study Overview
Status
Not yet recruiting
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.
Study Type
Interventional
Enrollment (Estimated)
129
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Information Group officer
- Phone Number: +86-0311-69085587
- Email: ctr-contact@cspc.cn
Study Locations
-
-
Shandong
-
Jinan, Shandong, China
- Shandong Tumor Hospital
-
Contact:
- Jin ming Yu
- Phone Number: 86-531-67627156
- Email: sdyujinming@126.com
-
-
Tianjin
-
Tianjin, Tianjin, China
- Tianjin cancer institute &hospital
-
Contact:
- Qing song Pang
- Phone Number: 86-18622221203
- Email: pangqingsong2016@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years (based on the day of signing the informed consent form).
- Voluntarily sign the informed consent, willing and able to follow the protocol for visits, treatment and laboratory tests.
- 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) .
- ECOG score of 0-1 within 7 days prior to the first dose.
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):
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelet count (PLT) ≥ 100×10^9/L
- Hemoglobin ≥ 80g/L
- Serum albumin ≥ 28g/L
- Total bilirubin ≤1.0×ULN; ALT/AST ≤1.5×ULN
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min, Cockcroft-Gault formula
- Activated Prothrombin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 x ULN.
- 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.
- Have at least one evaluable lesion per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
Exclusion Criteria:
- 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).
- 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.
- 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).
- 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.
- Severe allergy history to albumin or docetaxel, paclitaxel, cisplatin, or monoclonal antibody drugs.
- Patients who have received prior antitumor therapy for esophageal cancer.
- 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).
History of severe cardiovascular disease within 6 months prior to the first dose, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, Third-degree atrioventricular block
- History of myocardial infarction, unstable angina, angioplasty, coronary artery bridging surgery
- Heart failure with New York Heart Association (NYHA) classification of class III and above
- Left ventricular ejection fraction (LVEF) <50% at screening period
- Patients with prolonged QT/QTc interval on ECG at baseline (QTcF > 480ms, Fridericia formula: QTcF=QT/RR^0.33, RR=60/heart rate).
- Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during the screening period).
- 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.
- 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.
- History of interstitial lung disease or non-infectious pneumonia.
- Patients with known psychoneurologic disorders that may affect adherence to the trial, and those with a history of drug dependence;
- 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.
- Have received potent inhibitors or potent inducers of CYP2C8 (for Phase Ⅱ trials only) or CYP3A4 within 14 days prior to the first dose.
- Vaccination with a live or live attenuated vaccine (inactivated vaccines are permitted) within 28 days prior to the first dose.
- History of major organ surgery (excluding puncture biopsy) within 28 days prior to the first dose.
- Patients who have received antitumor therapy such as other clinical investigational drugs within 28 days prior to the first dose.
- Patients who have received systemic glucocorticoid therapy (dose > 10 mg/day of prednisone or equivalent) within 28 days prior to the first dose.
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy
SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; Docetaxel for Injection (Albumin-bound) (HB1801), Intravenous infusion, D1, Q3W, 60 or 75 mg/m^2, up to 2 cycles; cisplatin for injection 25 mg/m^2, D1-D3, Q3W, up to 2 cycles; radiotherapy (28×1.8Gy).All treatments will be administered until disease progression or intolerable toxicity.
|
Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m^2, Intravenous infusion, Q3W
Other Names:
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous infusion, Q3W
Other Names:
Cisplatin for injection, 25 mg/m^2, Intravenous infusion, D1-D3, Q3W
Radiotherapy (28×1.8Gy)
|
Active Comparator: Paclitaxel in combination with cisplatin and simultaneous radiotherapy
Paclitaxel 135 mg/m^2, Intravenous infusion, D1, Q3W; cisplatin for injection 25 mg/m^2, D1-D3, Q3W, radiotherapy (28×1.8Gy).
No other systemic antineoplastic therapy is allowed until disease progression, optimal supportive care and local palliative care are allowed.
|
Cisplatin for injection, 25 mg/m^2, Intravenous infusion, D1-D3, Q3W
Radiotherapy (28×1.8Gy)
Paclitaxel 135 mg/m^2, Intravenous infusion, Q3W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicity (DLT)
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
|
At the end of Cycle 1 (each cycle is 21 days)
|
Determine the recommended Phase 2 dose (RP2D) of Docetaxel for Injection (Albumin-bound)
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
|
At the end of Cycle 2 (each cycle is 21 days)
|
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ib
Time Frame: up to 4 years
|
up to 4 years
|
PFS as determined by the investigator according to RECIST 1.1 in Phase Ⅱ
Time Frame: up to 4 years
|
up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS)
Time Frame: up to 4 years
|
up to 4 years
|
Overall survival (OS)
Time Frame: up to 4 years
|
up to 4 years
|
Objective remission rate (ORR)
Time Frame: up to 4 years
|
up to 4 years
|
Disease control rate (DCR)
Time Frame: up to 4 years
|
up to 4 years
|
Duration of remission (DOR)
Time Frame: up to 4 years
|
up to 4 years
|
Incidence of SG001 antidrug antibodies and neutralizing antibodies (if applicable)
Time Frame: up to 4 years
|
up to 4 years
|
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ⅱ
Time Frame: up to 4 years
|
up to 4 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total docetaxel concentration in plasma and free docetaxel concentration
Time Frame: up to 4 years
|
up to 4 years
|
SG001 concentration in serum
Time Frame: up to 4 years
|
up to 4 years
|
To evaluate the correlation between PD-L1 expression and efficacy in tumor tissues
Time Frame: up to 4 years
|
up to 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2023
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
November 8, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Estimated)
November 17, 2023
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Docetaxel
- Paclitaxel
Other Study ID Numbers
- HB1801-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced Unresectable Esophageal Squamous Carcinoma
-
Cancer Institute and Hospital, Chinese Academy...Akeso Pharmaceuticals, Inc.Not yet recruitingMetastatic Esophageal Squamous Cell Carcinoma | Unresectable Esophageal Squamous Cell Carcinoma | Locally Advanced Esophageal Squamous Cell Carcinoma
-
Shanghai Chest HospitalRecruitingEsophageal Squamous Cell Carcinoma | Unresectable Locally Advanced Esophageal CancerChina
-
CStone PharmaceuticalsActive, not recruitingUnresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell CarcinomaChina
-
City of Hope Medical CenterNational Cancer Institute (NCI); Genentech, Inc.RecruitingLocally Advanced Skin Squamous Cell Carcinoma | Unresectable Skin Squamous Cell Carcinoma | Resectable Skin Squamous Cell CarcinomaUnited States
-
Shanghai Runshi Pharmaceutical Technology Co., LtdJilin Provincial Tumor HospitalRecruitingLocally Advanced Unresectable CarcinomaChina
-
Emory UniversityAstex Pharmaceuticals, Inc.RecruitingHead and Neck Carcinoma of Unknown Primary | Locally Advanced Head and Neck Squamous Cell Carcinoma | Locally Advanced Hypopharyngeal Squamous Cell Carcinoma | Locally Advanced Laryngeal Squamous Cell Carcinoma | Locally Advanced Nasopharyngeal Squamous Cell Carcinoma | Locally Advanced Oropharyngeal...United States
-
Memorial Sloan Kettering Cancer CenterRecruitingSkin Cancer | Squamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Locally Advanced Skin Squamous Cell Carcinoma | Locally Advanced Cutaneous Squamous Cell Carcinoma | Locally Advanced Squamous Cell Carcinoma | Locally Advanced Squamous Cell Carcinoma of the SkinUnited States
-
Jiangsu Cancer Institute & HospitalRecruitingLocally Advanced Esophageal CarcinomaChina
-
National Cancer Center, JapanOno Pharmaceutical Co. Ltd; Fiverings Co., Ltd.Active, not recruitingLocally Advanced Esophageal Squamous Cell CarcinomaJapan
-
National Taiwan University HospitalRecruitingLocally Advanced Esophageal Squamous Cell CarcinomaTaiwan
Clinical Trials on Docetaxel for Injection (Albumin-bound)
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingPancreatic CancerChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruiting
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Active, not recruitingAdvanced Solid TumorsChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingGastric Adenocarcinoma | Adenocarcinoma of Gastroesophageal JunctionChina
-
China Medical University, ChinaRecruiting
-
Sun Yat-sen UniversityJiangsu HengRui Medicine Co., Ltd.UnknownNon-Small Cell Lung CancerChina
-
Sun Yat-sen UniversityShanghai Junshi Bioscience Co., Ltd.; CSPC Ouyi Pharmaceutical Co., Ltd.RecruitingEsophageal Small Cell CarcinomaChina
-
Jiangsu Alphamab Biopharmaceuticals Co., LtdNot yet recruiting
-
Peking UniversityChia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingGastric Cancer | Adenocarcinoma of Esophagogastric JunctionChina
-
Fuzhou General HospitalUnknownNasopharyngeal CarcinomaChina