Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma

NCT04716751 | Unknown Phase 2

• 1 other identifier: LungMate-011(FK-NEO-TSCC-001)
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab + carboplatin + paclitaxel in 15 newly diagnosed patients with tracheal malignant tumors.

Conditions

Tracheal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Overall survival (OS)

  up to 60 months

• Progression-free survival (PFS)

  up to 60 months

• Duration of remission (DOR)

  up to 60 months

• Disease control rate (DCR)

  up to 60 months

• Health related quality of life (HRQol)

  up to 6 months

Study Arms (1)

Toripalimab

EXPERIMENTAL

Drug: Toripalimab

Interventions

Toripalimab DRUG

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).

Also known as: carboplatin, paclitaxel

Toripalimab

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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Interventions

toripalimab; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

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: Director of thoracic department

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 20, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: May 31, 2025
• Last Updated: January 26, 2021

Record last verified: 2021-01