- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04716751
Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma
Clinical Study of Neoadjuvant Anti-PD-1 Drug Toripalimab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bronchoscopic biopsy confirmed as tracheal malignant tumor by pathological examination
- PET-CT confirmed no metastasis;
- ECOG physical status score 0-1;
- Bronchoscopy, chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy.
- Age ≥ 18 years;
- Have one measurable lesions at least;
- Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
- Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of triplizumab, whichever is later, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after chemotherapy or the last administration of triplizumab, whichever is the later.
- Sign informed consent;
Exclusion Criteria:
- Systemic anticancer therapy for tracheal malignant tumors, including surgery, radiotherapy, chemotherapy, targeted therapy and experimental therapy.
- Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
- Patients with other malignant tumors in the five years before the start of this trial.
- Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- The infection was treated with antibiotics within 4 weeks before the start of the trial;
- A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
- Had or is suffering from nephrotic syndrome
- Has been or is suffering from chronic obstructive pneumonia, bronchiectasis, or interstitial lung disease;
- Allergic to experimental drugs;
- Complicated with HIV infection or active hepatitis.
- Vaccination within 4 weeks before the start of this trial;
- Those who had undergone other major operations or severe injuries within the previous 2 months;
- Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
- Pregnant or lactating women;
- Those with neurological diseases or mental disorders.
- Participated in another therapeutic clinical study at the same time;
- Other researchers did not consider it appropriate to enroll in the group.
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: Toripalimab
|
Neoadjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ paclitaxel 200 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with tracheal malignant tumor received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion. Adjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ paclitaxel 200 mg/m ²,iv, up to 4 cycles (including neoadjuvant stage).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: frequency of severe adverse events
Time Frame: up to 5 months
|
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
|
up to 5 months
|
Major pathologic response (MPR)
Time Frame: up to 4 months
|
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
|
up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: up to 60 months
|
It is defined as the time from enrollment to death of participant due to any cause.
In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
|
up to 60 months
|
Duration of remission (DOR)
Time Frame: up to 60 months
|
According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1,
whichever occurs first.
|
up to 60 months
|
Disease control rate (DCR)
Time Frame: up to 60 months
|
The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation
|
up to 60 months
|
Progression-free survival (PFS)
Time Frame: up to 60 months
|
PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1,
whichever occurs first.
|
up to 60 months
|
Health related quality of life (HRQol)
Time Frame: up to 6 months
|
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3).
EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items.
Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options.
The other items are divided into 4 grades
|
up to 6 months
|
Collaborators and Investigators
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
- 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
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- LungMate-011(FK-NEO-TSCC-001)
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.
Clinical Trials on Tracheal Squamous Cell Carcinoma
-
National Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage... and other conditionsCanada, United States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Emory UniversitySynta Pharmaceuticals Corp.TerminatedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage I Hypopharyngeal Squamous Cell Carcinoma | Stage I Laryngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II... and other conditionsUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
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
-
NRG OncologyNational Cancer Institute (NCI)RecruitingAdvanced Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of Unknown Primary | Advanced Hypopharyngeal Squamous Cell Carcinoma | Advanced Laryngeal Squamous Cell Carcinoma | Advanced Oropharyngeal Squamous Cell CarcinomaUnited States, Canada
-
H. Lee Moffitt Cancer Center and Research InstituteAstraZeneca; Brooklyn ImmunoTherapeutics, LLCActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Oropharynx Squamous Cell Carcinoma | Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma | Hypopharynx Squamous Cell Carcinoma | Paranasal Sinus Squamous Cell Carcinoma | Larynx Squamous Cell CarcinomaUnited States
-
Baptist Health South FloridaRegeneron PharmaceuticalsWithdrawnSquamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Advanced Squamous Cell CarcinomaUnited States
-
UNC Lineberger Comprehensive Cancer CenterMayo Clinic; National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCarcinoma, Squamous Cell | Head and Neck Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | Oropharynx Squamous Cell CarcinomaUnited States
Clinical Trials on Toripalimab
-
Mabwell (Shanghai) Bioscience Co., Ltd.Not yet recruitingAdvanced Urothelial CarcinomaChina
-
Henan Cancer HospitalUnknownEsophageal Squamous Cell Carcinoma
-
Sun Yat-sen UniversityThe First Affiliated Hospital of Guangzhou Medical University; Guangzhou Panyu...RecruitingStudy of Toripalimab for Limited-Stage Small Cell Lung Cancer Following Concurrent ChemoradiotherapySmall Cell Lung Cancer Limited StageChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHead and Neck Squamous Cell CarcinomasChina
-
Shanghai Junshi Bioscience Co., Ltd.Not yet recruitingMelanoma | Breast Cancer | Lung CanceChina
-
Zhejiang Genfleet Therapeutics Co., Ltd.CompletedAdvanced Solid TumorChina, Australia
-
Fudan UniversityUnknownMelanoma Stage IIIB-IVChina
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingLimited-stage Small Cell Lung Cancer (LS-SCLC)China, Taiwan, Georgia, United States
-
Tianjin Medical University Cancer Institute and...Not yet recruiting
-
Qianfoshan HospitalRecruiting