- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04937673
The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Camrelizumab Combined With Chemotherapy for Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma:A Phase II Clinical Study to Explore the Relationship Between Biomarkers and Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Department of GI Oncology, Peking University Cancer Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-75 years old, male or female;
- Esophageal squamous cell carcinoma was confirmed by pathology (except for cervical and Suprathoracic tumors that could not be operated);
- Patients with resectable esophageal squamous cell carcinoma with clinical stage T3-T4a or TxN + M0 (except T4b);
- ECOG PS score was 0-1;
- There was at least one measurable lesion (according to recist1.1) or unmeasurable lesion that could be evaluated, and the imaging diagnosis time was ≤ 21 days;
- The expected survival time was more than 3 months;
The function of the main organs was normal, and there were no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency diseases. The laboratory examination meets the following requirements:
- Hemoglobin (Hb) ≥ 90g / L;
- WBC ≥ 3.0 × 109/L; Neutrophil count (NEUT) ≥ 1.5 × 109/L;
- Platelet count (PLT) ≥ 100 × 109/L;
- Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml / min (Cockcroft Gault formula);
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- The levels of AST and ALT were less than 2.5 times the upper limit of normal (ULN);
There was no active bleeding or thrombosis
- International normalized ratio INR ≤ 1.5 × ULN;
- Partial thromboplastin time APTT ≤ 1.5 × ULN;
- Prothrombin time Pt ≤ 1.5ULN;
- The patients with normal or mild to moderate abnormal lung function (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco> 40%) could tolerate esophagectomy;
- The fertile female subjects were required to conduct blood pregnancy test within 72 hours before the first administration, and the result was negative, and voluntarily used appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug; For men, surgical sterilization or consent to appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug should be used.
- The subjects voluntarily joined the study and signed the informed consent form (ICF);
- The patients with good compliance were expected to follow up the efficacy and adverse events / reactions according to the protocol requirements.
Exclusion Criteria:
- Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
- Immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
- Live attenuated vaccine was inoculated within 4 weeks before the first administration or during the study period;
- Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg);
- Subjects with uncontrollable clinical cardiac symptoms or diseases, such as (1) heart failure of NYHA II or above (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown origin > 38.5% occurred during the screening period / before the first administration;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known;
- Pregnant or lactating women; The fertile subjects were unwilling or unable to take effective contraceptive measures;
- Other malignant tumors were found in the past or at the same time, but the cured basal cell carcinoma of skin, carcinoma in situ of cervix and carcinoma in situ of breast were excluded;
- Known to have allergic history to the drug components of this protocol;
- Other situations considered unsuitable by the researchers.
Study Plan
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: Camrelizumab+ Paclitaxel+ Cisplatin
The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1.
Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation).
At the end of the treatment, the patients were followed up for safety and effectiveness.
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Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks. |
Experimental: Camrelizumab+ Albumin bound paclitaxel+ Cisplatin
The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1.
Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation).
At the end of the treatment, the patients were followed up for safety and effectiveness.
|
Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biomarkers related to pCR
Time Frame: 9 weeks
|
t has a good value in predicting the efficacy of immunotherapy, and is helpful for the accurate formulation of treatment plan and the accurate evaluation of prognosis of patients with esophageal cancer.
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9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: 9 weeks
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Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
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9 weeks
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Disease Control Rate
Time Frame: 9 weeks
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Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
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9 weeks
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Disease free survival
Time Frame: Time from randomization to patient's tumor progression or death
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The DFS will be defined as the time of patients alive without local recurrence or distant metastasis of disease from the date of the administration of treatment.
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Time from randomization to patient's tumor progression or death
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Overall Survival
Time Frame: The time from the beginning of randomization to death due to any cause.
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OS is defined as the time from registration to death due to any cause, or censored at date last known alive.
Measured by the method of Kaplan and Meier
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The time from the beginning of randomization to death due to any cause.
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Safety
Time Frame: from first treatment to 90 days after esophagectomy
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Adverse events
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from first treatment to 90 days after esophagectomy
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- MA-EC-II-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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