Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma

NCT05964101 | Recruiting Phase 2

• 1 other identifier: ES-2023-062-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.

Conditions

Neoplasms; Carcinoma, Squamous; Antineoplastic Agents

Keywords

tracheal tumor; neoadjuvant immunochemotherapy; surgery

Outcome Measures

Primary Outcomes (2)

• Major pathologic response (MPR)

  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

• Safety: frequency of severe adverse events

  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

Secondary Outcomes (5)

• Progression-free survival (PFS)

  up to 24 months

• Overall survival (OS)

  up to 60 months

• Disease control rate (DCR)

  up to 60 months

• Duration of remission (DOR)

  up to 60 months

• R0 rate

  up to 4 months

Study Arms (1)

Nivolumab

EXPERIMENTAL

Neoadjuvant treatment stage: Nivolumab 360mg, Carboplatin AUC5+ paclitaxel 100 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with primary tracheal squamous cell carcinoma received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.

Drug: Nivolumab Injection [Opdivo]

Interventions

Nivolumab Injection [Opdivo] DRUG

Neoadjuvant treatment stage: Nivolumab +Carboplatin AUC+ paclitaxel

Also known as: carboplatin, paclitaxel

Nivolumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination
• PET-CT confirmed no metastasis;
• ECOG physical status score 0-1;
• Bronchoscopy, and 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 lesion 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 Nivolumab, 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 Nivolumab, whichever is the latter.
• Sign informed consent;

You may not qualify if:

• 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;
• 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 is suffering from nephrotic syndrome
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carcinoma, Squamous Cell; Tracheal Neoplasms

Interventions

Nivolumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Respiratory Tract Diseases; Tracheal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Shuben Li, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Shuben Li, PhD

CONTACT

+8613500030280; 13500030280@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 27, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: May 31, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)