Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.
Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Jiancheng Li, Doctor
- Phone Number: 13906900190
- Email: jianchengli6@126.com
Study Locations
-
-
-
Fuzhou, China
- Recruiting
- Fujian Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sign written informed consent and voluntarily participate in this study;
- Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB;
- Survival is expected to exceed 3 months
- Age 18-75;
- ECOG PS 0-2
- Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;
- Have at least one measurable lesion
Normal function of major organs, including:
Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs)
White blood cell count ≥ 3.0×10^9/L
Neutrophil count ≥ 1.0×10^9/L
Platelet count ≥ 80×109/L
Hemoglobin ≥ 80 g/L
- Blood biochemical examination:
Total bilirubin ≤ 1.5×ULN
ALT ≤2.5×ULN, AST ≤2.5×ULN,
Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min
- Subjects have good compliance and cooperate with follow-up
Exclusion Criteria:
- The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;
- Poor nutritional status, BMI < 18.5 Kg/m^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator;
- Gastrointestinal bleeding (bleeding volume > 200ml/ day);
- Patients with deep ulcers as determined by the investigator;
- Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs;
Has received or is receiving any of the following medical treatment:
- any radiation, chemotherapy or other antitumor drugs for the tumor;
- Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose >10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of >10mg/ day or its equivalent are permitted;
- Received live attenuated vaccine within 4 weeks before the first administration of the study drug;
- Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included;
- A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to:
Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention;
- Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;
- Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;
- The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit);
- In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: drug
|
200mg intravenous drip d1q3w
150mg/m2 d1 q3w
Cisplatin, carboplatin, nedaplatin and other platinum drugs
Dose: 5040cGy/28f
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Response Rate(ORR)
Time Frame: 3 years
|
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
|
3 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival(OS)
Time Frame: 3 years
|
Defined as the time from the enrollment to death from any cause
|
3 years
|
|
Progression free survival(PFS)
Time Frame: 3 years
|
It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
|
3 years
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Esophageal Neoplasms
- Esophageal Diseases
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
Other Study ID Numbers
- Advanced immunotherapy CRT
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
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