- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05022654
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.
Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 Combined With Irinotecan in the Treatment of Recurrent and Metastatic Esophageal Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hai Zhu
- Phone Number: +8613980051002
- Email: zhuhai@baili-pharm.com
Study Contact Backup
- Name: Sa Xiao
- Phone Number: +8615013238943
- Email: xiaosa@baili-pharm.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hostital
-
Contact:
- Lin Shen
- Phone Number: 01088196561
- Email: doctorshenlin@sina.cn
-
-
Henan
-
Anyang, Henan, China
- Recruiting
- Anyang Cancer Hospital of Henan Province
-
Contact:
- Junsheng Wang
-
Luoyang, Henan, China
- Recruiting
- The First Affiliated Hospital of Henan University of Science and Technology
-
Contact:
- Shegan Gao
-
-
Jiangsu
-
Xuzhou, Jiangsu, China
- Recruiting
- Xuzhou Central Hospital
-
Contact:
- Yuan Yuan
-
-
Shanxi
-
Taiyuan, Shanxi, China
- Recruiting
- Shanxi Cancer Hospital
-
Contact:
- Mudan Yang
-
-
Sichuan
-
Suining, Sichuan, China
- Recruiting
- Suining Central Hospital
-
Contact:
- Na Li
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- Male or female, age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Locally advanced esophageal squamous cell carcinoma confirmed histologically or pathologically as recurrent or metastatic or without indications of radical local treatment;
- Patients who failed or were intolerant to first-line anti-PD-1 (L1) monoclonal antibody plus platinum-based chemotherapy
- Agree to provide archived tumor tissue specimens of primary or metastatic lesion (4 surgical specimens (thickness 5μm) without staining section (anti-removal);6 unstained sections (anti-removal) surgical specimens (thickness 10μm) or fresh tissue samples, if the patient cannot provide, can be included after the investigator's judgment;
- There must be at least one measurable lesion conforming to the RECIST V1.1 definition. Tumor lesion located in the area of previous radiotherapy or other local and regional treatment sites is generally not a measurable lesion unless there is definite progression of the lesion or the lesion persists three months after radiotherapy;
- Physical fitness ECOG score of 0 or 1;
- Toxicity from previous antitumor therapy has returned to ≤1 as defined by NCI-CTCAE V5.0 (except for toxicity that the investigators determined to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stabilized hypothyroidism after hormone replacement therapy);
Organ function levels must meet the following requirements and meet the following standards:
A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours < 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
- Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the trial and for at least 6 months after the last medication;Women of childbearing age must have a negative blood or urine pregnancy test within 7 days prior to the first use of the study drug.
Exclusion Criteria:
Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except for the following:
Oral fluorouracil and small molecule targeted drugs were used within 2 weeks before the first administration of the study drug or within 5 half-lives of the drug; The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
- Patients with esophageal fistula;
- Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to initial use of the investigational drug;
- Had major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or had significant trauma within 4 weeks prior to the first use of study drugs, or needed to undergo elective surgery during the trial;
- Previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade iii atrioventricular block, etc; In the resting state, QT interval was prolonged (QTc > 450 msec in men or QTc > 470 msec in women); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardio-cerebrovascular events within 6 months prior to the first administration; New York Heart Association (NYHA) heart function grade ≥II heart failure;
- Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, inflammatory bowel disease, etc., except type I diabetes, hypothyroidism that can be controlled only with replacement therapy, and skin diseases that do not require systemic treatment;
- Patients with a history of other malignant tumors and signs of recurrence and metastasis within 1 year before the first administration;
- Poorly controlled hypertension (systolic blood pressure & GT;150 mmHg or diastolic pressure >100 mmHg);
- Pulmonary disease of grade 3 or higher defined by CTCAE V5.0;Patients with past or present interstitial lung disease (ILD);
- Cerebral parenchymal or meningeal metastases with clinical symptoms were not suitable for inclusion.
- Previous use of anti-EGFR antibody drug therapy;
- There are known allergic contraindications to any excipients of SI-B001 or irinotecan;
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, septicemia, etc;'
- Pregnant or lactating women;
- Persons with mental disorders or poor compliance;
- The investigator considers that the subject has a history of other serious systemic diseases or other reasons to be unsuitable for this clinical study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SI-B001 combined with irinotecan
Patients with recurrent metastatic esophageal squamous cell carcinoma who had failed first-line therapy with PD-1(L1) monoclonal antibody plus platinum-based chemotherapy were enrolled.
|
Administered by intravenous drip every 2 weeks (Q2W).
The first intravenous infusion is 120 min±10min.
If the infusion reaction can be tolerated during the first infusion, the subsequent infusion can be completed in 60-120 min.
The dose of irinotecan was 180mg/m2 Q2W, the infusion method was according to the drug instructions, SI-B001 and irinotecan were used on the same day, and irinotecan was injected after SI-B001 infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: Up to approximately 24 months
|
objective response rate
|
Up to approximately 24 months
|
Optimal combination dose (only IIa)
Time Frame: Up to approximately 24 months
|
Optimal combination dose of SI-B001 with irinotecan(only IIa)
|
Up to approximately 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: Up to approximately 24 months
|
Progression-Free-Survival
|
Up to approximately 24 months
|
DCR
Time Frame: Up to approximately 24 months
|
Disease-control rate
|
Up to approximately 24 months
|
DOR
Time Frame: Up to approximately 24 months
|
Duration of Response
|
Up to approximately 24 months
|
OS
Time Frame: Up to approximately 24 months
|
Overall Survival
|
Up to approximately 24 months
|
TEAE
Time Frame: Up to approximately 24 months
|
Treatment Emergent Adverse Events
|
Up to approximately 24 months
|
Cmax
Time Frame: Up to approximately 24 months
|
Maximum serum concentration
|
Up to approximately 24 months
|
Tmax
Time Frame: Up to approximately 24 months
|
Time to maximum serum concentration
|
Up to approximately 24 months
|
Ctrough
Time Frame: Up to approximately 24 months
|
Minimum serum concentration
|
Up to approximately 24 months
|
ADA
Time Frame: Up to approximately 24 months
|
anti-SI-B001 antibody
|
Up to approximately 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: lin Shen, Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- SI-B001_207
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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