To hear about similar clinical trials, please enter your email below
Trial Title:
Tislelizumab and Induction Chemotherapy for Larynx Preservation in Resectable Advanced Laryngeal/Hypopharyngeal Cancer
NCT ID:
NCT06554028
Condition:
Laryngeal Cancer
Hypopharynx Cancer
Laryngeal Neoplasms
Conditions: Official terms:
Laryngeal Neoplasms
Hypopharyngeal Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chemotherapy TP regimen combined with Tislelizumab
Description:
Induction chemotherapy TP regimen combined with Tislelizumab for 3 cycles: Cisplatin
37.5mg/m2 d1-2 q3w, Docetaxel 37.5mg/m2 d1and d3 q3w,Tislelizumab 200mg d3 q3w.
•Response rate of primary tumor or lymph nodes is evaluated using laryngoscopy and head
and neck MRI after 3 cycles of induction therapy. If the primary lesion reaches CR/PR and
the lymph nodes reach CR, chemoradiotherapy based on cisplatin is conducted. If the
primary lesion reaches CR/PR and lymph node PR/PD, cervical lymph node dissection will be
performed, followed by radiotherapy/concurrent chemoradiotherapy. If the primary lesion
is SD/PD, regardless of the condition of the lymph nodes, primary lesion resection and
lymph node dissection should be performed, followed by adjuvant radiation/chemoradiation.
Other Names:
Docetaxel Cisplatin Paclitaxel
Arm group label:
Tislelizumab and Induction Chemotherapy Followed by Radiotherapy or Adaptive Surgery
Summary:
This study is a prospective, single-arm, single-center, phase II study. The goal of this
clinical trial is to explore the therapeutic value of the treatment model of
"tislelizumab combined with chemotherapy followed by radiotherapy/adaptive surgery" on
larynx Preservation of locally advanced hypopharyngeal cancer and laryngeal cancer.
Detailed description:
Historical studies have shown that induction chemotherapy can provide an opportunity to
preserve the larynx in approximately 60-70% of patients with locally advanced
laryngeal/hypopharynx carcinoma. Recently, phase I-II clinical studies have shown that
induction of PD-1 inhibitors has a good pathological response in locally advanced head
and neck cancer, with or without combined chemotherapy. However,the primary lesion and
lymph nodes respond asynchronously or even in the opposite way to immune induction
therapy. The primary lesion is more likely to achieve CR/PR, while the lymph nodes are
more likely to show PR/SD or even PD. Therefore, the surgical or radiotherapy plan should
be implemented according to the specific response of the primary lesion and metastatic
lymph nodes to induction therapy. This study aimed to determine whether the combination
of induction chemotherapy with a PD-1 inhibitor (Tislelizumab) followed by
chemoradiotherapy or adaptive surgery can improve the rate of laryngeal preservation in
patients with resectable laryngeal/hypopharynx cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal
squamous cell carcinoma (T2-4a, N0-resectable N3, M0);
2. Age between 18-70 years;
3. Had at least one measurable lesion according to RECIST 1.1 criteria;
4. Anticipated overall survival more than 3 months;
5. Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale
0-1;
6. Normal organ function;
7. Male and no pregnant female, able to adapt birth control methods during treatment;
8. Signed inform consent;
Exclusion Criteria:
1. Hypersensitivity to tislelizumab, Paclitaxel or Cisplatin.
2. Received anti-tumor treatment in the past 6 months, including radiotherapy and
chemotherapy, surgery, immunotherapy.
3. Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid
carcinoma, or skin cancer (non- melanoma) within five years.
4. There is distant metastasis.
5. Active autoimmune diseases, history of autoimmune diseases (such as interstitial
pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,
hypothyroidism, including but not limited to these diseases or syndromes); but
excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement
hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood
asthma/allergies, Patients who do not require any intervention after adulthood.
6. Known history of primary immunodeficiency (including positive HIV test, or suffering
from other acquired or congenital immunodeficiency diseases, or history of organ
transplantation and allogeneic bone marrow transplantation);
7. Severe infection occurred within 4 weeks before the first use of the study drug,
such as severe pneumonia requiring hospitalization, bacteremia, infection
complications, etc.
8. The subject has severe liver and kidney dysfunction, HIV infection, HCV infection,
uncontrolled clinical symptoms or diseases of the heart, such as: heart failure
above NYHA grade II or echocardiography，showing left ventricular ejection fraction
(LVEF) < 50%; unstable angina; myocardial infarction within 1 year; patients with
clinically significant supraventricular or ventricular arrhythmias requiring
clinical，intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes,
uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive
encephalopathy or other diseases considered by the researchers to be ineligible.
9. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA
exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be
excluded; inactive hepatitis B surface Antigen carriers, treated and stable
hepatitis B patients (HBV DNA<500IU/ml), and cured hepatitis C patients can be
enrolled.
10. Have a history of interstitial lung disease (excluding radiation pneumonitis that
has not been treated with hormones) and non-infectious pneumonia.
11. Active tuberculosis infection was found through medical history or CT examination,
or patients with a history of active tuberculosis infection within 1 year before
enrollment, or patients with a history of active tuberculosis infection more than 1
year ago but without formal treatment.
12. Patients who have received any of the following treatments (1) Subjects who need to
be given corticosteroids (> 10 mg prednisone equivalent dose per day) or other
immunosuppressants for systemic treatment within 2 weeks before the first use of the
study drug, except for local inflammation and prevention of allergies and nausea,
Cases of use of corticosteroids for vomiting. In the absence of active autoimmune
disease, corticosteroid replacement with inhaled or topical steroids and curative
doses of prednisone >10 mg/day is permitted; (2) Have been vaccinated against
tumors; those who have been vaccinated or have been vaccinated with live vaccines
within 4 weeks before the first administration of the study drug; (3) Received major
surgery or severe trauma within 4 weeks before the first use of the study drug; (4)
Enrolled in another clinical study at the same time.
13. Pregnant and lactating women. Women of childbearing age must take a pregnancy test
within 7 days before enrollment Negative.
14. Substance abuse, clinical or psychological or social factors that hinder informed
consent or research conduct influences.
15. Any uncertain factors affecting the safety or compliance of the subjects.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Defeng Chen, MD
Phone:
+8615638273018
Email:
zlyychendefeng3018@zzu.edu.cn
Start date:
August 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06554028
