Trial Title:
A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05783921
Condition:
Recurrent Squamous Cell Carcinoma of the Head and Neck
Metastatic Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Description:
TQB2618 injection is an Anti TIM-3 (T-cell immunoglobulin and mucin domain-3) monoclonal
antibody.
Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death
Protein 1 (PD-1).
Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits
depolymerization, maintains tubulin stability and inhibits cell mitosis.
Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with
DNA. Protein and RNA synthesis can also be inhibited.
Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA
strands and affect their synthesis to inhibit cancer cells.
Arm group label:
TQB2618 injection +Penpulimab injection+Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)
Intervention type:
Drug
Intervention name:
Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Description:
Penpulimab injection is a humanized Monoclonal Antibody target Programmed Cell Death
Protein 1 (PD-1).
Paclitaxel is a anti-microtubule drug, which promotes tubulin polymerization, inhibits
depolymerization, maintains tubulin stability and inhibits cell mitosis.
Cisplatin inhibits DNA synthesis by generating in-strand interstrand crosslinking with
DNA. Protein and RNA synthesis can also be inhibited.
Carboplatin is a cyclic nonspecific antitumor agents that cause cross-linking between DNA
strands and affect their synthesis to inhibit cancer cells.
Arm group label:
Penpulimab injection + Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)
Summary:
To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and
chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous
cell carcinoma compared to Penpulimab combined chemotherapy.
Progression-free survival (PFS) and objective response rate (ORR) were the primary
efficacy endpoints.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The subjects voluntarily joined the study, signed the informed consent form, and had
good compliance.
- Between the ages of 18-75 years (calculated based on the date of signing ICF); male
or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival
time ≥ 3 months.
- No indications of local radical therapy for recurrence/metastasis head and neck
squamous cell carcinoma.And histologically- or cytologically-confirmed head and neck
squamous cell carcinoma ，Primary tumor locations of oropharynx, oral cavity,
hypopharynx, or larynx.
- No systemic therapy for recurrent/metastatic lesions, but excluding systemic therapy
for locally advanced disease as a part of multimodal therapy (including induction
therapy, systemic therapy in the same period of radiotherapy, and adjuvant therapy),
and the completion time of treatment was more than 6 months from enrollment
(according to the date of informed consent);
- At least one measurable lesion (based on RECIST1.1).
- The main organs function are normally, the following criteria are met:
1. hemoglobin (Hb) ≥90g/L (no blood transfusion and blood products within 14 days)
；absolute neutrophil count (ANC) ≥1.5×109/L； platelets (PLT) ≥90×109/L.
2. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.
If accompanied by liver metastases, ALT and AST ≤ 5×ULN; Serum creatinine (CR)
≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min.
3. Prothrombin time (PT), activated partial thromboplastin time (APTT),
international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);
Thyroid-stimulating hormone (TSH) ≤ ULN; If abnormalities should be examined,
T3 and T4 levels should be examined, and T3 and T4 levels are normal.
4. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Female participants of childbearing age should agree to use contraception (e.g.,
IUDs, pills, or condoms) during the study period and for 6 months after the end of
the study; Have a negative serum pregnancy test within 7 days prior to study
enrollment and must be a non-lactating subject; Male participants should agree that
contraception must be used during the study period and for 6 months after the end of
the study period.
Exclusion Criteria:
- Comorbidity and medical history:
1. Have had or currently have other malignant tumors within 3 years. The following
two conditions can be enrolled: other malignancies treated with a single
surgery to achieve 5-year disease-free survival (DFS); cured cervical carcinoma
in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta
(non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement
membrane)];
2. adverse effects due to any prior treatment have not been restored to CTCAE 5.0
≤ level 1 (except for toxicity where the investigator determines that there is
no safety risk);
3. Major surgical treatment, incision biopsy, or significant traumatic injury were
received within 28 days prior to study treatment
4. Long-term unhealed wounds or fractures
5. Arteriovenous thrombotic events within 6 months, such as cerebrovascular
accidents;
6. Those who have a history of psychotropic substance abuse and cannot quit or
have a mental disorder;
7. Subjects with any severe and/or uncontrolled medical conditions, including:
1. Unsatisfactory blood pressure control (systolic blood pressure ≥ 150mmHg
or diastolic blood pressure ≥100 mmHg);
2. Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmias
(including QTc ≥ 450 ms (male) in men and QTc ≥ 470 ms (female)) and grade
≥ congestive heart failure grade 2 (New York Heart Association (NYHA)
grade);
3. Active or uncontrolled severe infection (≥ CTC AE grade 2 infection) or
unexplained fever > 38.5°C;
4. Liver cirrhosis, active hepatitis Note: Active hepatitis (hepatitis B
reference: HBsAg positive and HBV (hepatitis B virus) DNA detection value
of more than 1000 copies /mL; Hepatitis C reference: HCV (hepatitis C
virus) antibody positive, and HCV virus titer test value above the upper
limit of normal);
5. Known to have syphilis;
6. Renal failure requires hemodialysis or peritoneal dialysis
7. A history of immunodeficiency, including HIV positive or other acquired or
congenital immunodeficiency diseases, or a history of organ
transplantation;
8. Poor diabetes control [fasting blood glucose (FBG) > 10mmol/L]
9. Urine routine indicated urine protein ≥++, and confirmed 24 hours urine
protein quantity > 1.0 g
10. People who have epilepsy and need treatment
- Tumor related symptoms and treatment
1. Study history of surgery, chemotherapy, radiotherapy, or other anticancer
therapy within 4 weeks prior to the start of treatment (washout period from the
end of the last treatment)；
2. progress during or within 6 months of completion of systemic therapy (including
induction therapy, concurrent radiotherapy, adjuvant therapy) for locally
advanced disease;
3. Secondary radiotherapy was performed for local recurrent lesions;
4. Received Chinese patent drugs with anti-tumor indications specified in the
Chinese National Medical Product Administration approved drug instructions
within 1 week before the study treatment;
5. Have received relevant immunotherapy drugs in the past;
6. where imaging (CT or MRI) shows that the tumor has invaded important blood
vessels, or the investigator determines that the tumor is highly likely to
invade important blood vessels and cause fatal massive bleeding during the
follow-up study period;
7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
repeated drainage (investigator's judgment)
8. Subjects with known central nervous system metastatic and/or cancerous
meningitis;
- Research and treatment related:
1. Study history of live attenuated vaccine vaccination within 28 days before the
start of treatment or planned live attenuated vaccine vaccination during the
study period;
2. Patients with a definite tendency to bleed or clinically significant bleeding
symptoms, including but not limited to gastrointestinal bleeding, nasal
bleeding, and hemorrhagic disease or coagulopathy within 28 days prior to
initial medication;
3. People who have experienced severe hypersensitivity after the use of monoclonal
antibodies, or are allergic to known components of the drug under study;
4. Study of active autoimmune diseases requiring systemic treatment that occurred
within 2 years prior to initiation of treatment;
5. Have been diagnosed with immunodeficiency or are receiving systemic
glucocorticoid therapy or any other form of immunosuppressive therapy (dose >
10mg/ day prednisone or other efficacy hormone) and continue to use within 2
weeks before the study therapy begins;
- Participated in clinical trials of other antitumor drugs within 4 weeks before the
first medication;
- Subjects who, in the judgment of the investigator, have concomitant diseases that
seriously endanger the safety of the subjects or affect the completion of the study,
or subjects who are not suitable for inclusion for other reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gansu Prouincial Cancer Hospital
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Wang
Phone:
+86 13893338170
Email:
jack3376@126.com
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529030
Country:
China
Status:
Recruiting
Contact:
Last name:
Fangming Li
Phone:
+86 13528342766
Email:
342674168@qq.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
Song Qu, Doctor
Phone:
+86 13607887386
Email:
daisyqs@163.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Wu
Phone:
+86 15303608800
Email:
w.u-jin@163.com
Facility:
Name:
AnYang Tumor Hospital
Address:
City:
Anyang
Zip:
455000
Country:
China
Status:
Recruiting
Contact:
Last name:
YongGui Hong
Phone:
+86 13525836556
Email:
hygsir168@126.com
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiye Zhang
Phone:
+86 13783100985
Email:
13783100985@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Zong, Doctor
Phone:
+86 13523586882
Email:
zonghong522@126.com
Facility:
Name:
Zhumadian Centre Hospital
Address:
City:
Zhumadian
Zip:
463003
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunfang Chen
Phone:
+86 13783961672
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yaqian Han
Phone:
+86 18673176667
Email:
hanyaqian@hnca.org.cn
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingao Li, Doctor
Phone:
+86 13970866296
Email:
lijingao@hotmail.com
Facility:
Name:
Liaoning Cancer hospital
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhendong Li, Doctor
Phone:
+86 18900917937
Email:
1349946150@qq.com
Facility:
Name:
The Second Hospital Of Dalian Medical University
Address:
City:
Shenyang
Zip:
116027
Country:
China
Status:
Recruiting
Contact:
Last name:
XiuHua Sun
Phone:
+86 17709873631
Email:
3038668@vip.sina.com
Start date:
May 23, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05783921
