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Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 1/2NCT05783921

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

A Phase 1/2 study testing TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin and Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin in people with Recurrent Squamous Cell Carcinoma of the Head and Neck and Metastatic Squamous Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin and Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
12 sitesChina
Study dates
23 May 2023to Jan 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Comorbidity and medical history:
  • 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)];
  • 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);
  • Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment
  • Long-term unhealed wounds or fractures
  • Arteriovenous thrombotic events within 6 months, such as cerebrovascular accidents;
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  • Those who have a history of psychotropic substance abuse and cannot quit or have a mental disorder;
  • Subjects with any severe and/or uncontrolled medical conditions, including:
  • Unsatisfactory blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥100 mmHg);
  • 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);
  • Active or uncontrolled severe infection (≥ CTC AE grade 2 infection) or unexplained fever > 38.5°C;
  • 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);
  • Known to have syphilis;
  • Renal failure requires hemodialysis or peritoneal dialysis
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Poor diabetes control [fasting blood glucose (FBG) > 10mmol/L]
  • Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity > 1.0 g
  • People who have epilepsy and need treatment
  • Tumor related symptoms and treatment
  • 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)；
  • progress during or within 6 months of completion of systemic therapy (including induction therapy, concurrent radiotherapy, adjuvant therapy) for locally advanced disease;
  • Secondary radiotherapy was performed for local recurrent lesions;
  • 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;
  • Have received relevant immunotherapy drugs in the past;
  • 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;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (investigator's judgment)
  • Subjects with known central nervous system metastatic and/or cancerous meningitis;
  • Research and treatment related:
  • 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;
  • 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;
  • People who have experienced severe hypersensitivity after the use of monoclonal antibodies, or are allergic to known components of the drug under study;
  • Study of active autoimmune diseases requiring systemic treatment that occurred within 2 years prior to initiation of treatment;
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites, 12 recruiting

  • AnYang Tumor Hospital

    Anyang, Henan, 455000

    YongGui Hong, +86 13525836556, hygsir168@126.com

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Yaqian Han, +86 18673176667, hanyaqian@hnca.org.cn

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Jin Wu, +86 15303608800, w.u-jin@163.com

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

    Fangming Li, +86 13528342766, 342674168@qq.com

    Recruiting

  • Gansu Prouincial Cancer Hospital

    Lanzhou, Gansu, 730000

    Jun Wang, +86 13893338170, jack3376@126.com

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Zhiye Zhang, +86 13783100985, 13783100985@163.com

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330006

    Jingao Li, Doctor, +86 13970866296, lijingao@hotmail.com

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530000

    Song Qu, Doctor, +86 13607887386, daisyqs@163.com

    Recruiting

  • Liaoning Cancer hospital

    Shenyang, Liaoning, 110000

    Zhendong Li, Doctor, +86 18900917937, 1349946150@qq.com

    Recruiting

  • The Second Hospital Of Dalian Medical University

    Shenyang, Liaoning, 116027

    XiuHua Sun, +86 17709873631, 3038668@vip.sina.com

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Hong Zong, Doctor, +86 13523586882, zonghong522@126.com

    Recruiting

  • Zhumadian Centre Hospital

    Zhumadian, Henan, 463003

    Yunfang Chen, +86 13783961672

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open, Multicenter Phase 1/Phase 2 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

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.

Being tested
TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or CarboplatinDrug

    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.

  • Penpulimab injection, Paclitaxel, Cisplatin or CarboplatinDrug

    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.

Study groups in NCT05783921
Study groupRoleWhat they receive
TQB2618 injection +Penpulimab injection+Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)ExperimentalTQB2618 injection combined with Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4~6 cycles, TQB2618 injection combined with Penpulimab injection, 21 days as a treatment cycle.
Receives: Drug: TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin
Penpulimab injection + Chemotherapy (Paclitaxel+Cisplatin or Carboplatin)Active comparatorPenpulimab injection combined with Paclitaxel, Cisplatin or Carboplatin, 21 days as a treatment cycle. After 4~6 cycles, Penpulimab injection, 21 days as a treatment cycle.
Receives: Drug: Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    The time period from the first administration of the drug to disease progression or death event (whichever occurs first).

    Measured: Baseline to up to two years.

  2. Objective response rate (ORR)

    According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first administration of the drug to disease progression or initiation of a new anticancer treatment.

    Measured: Baseline to up to two years.

Secondary outcomes (8)

  1. PFS rate at 9 months

    Proportion of survived participants without progression at 9th months.

    Measured: Baseline to 9 months

  2. Overall survival (OS)

    Time from the randomization to death from all causes.

    Measured: Baseline to up to two years.

  3. Disease Control Rate (DCR)

    The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by investigators according to RECIST 1.1.

    Measured: Baseline to up to two years.

  4. Clinical benefit rate (CBR)

    The percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) for 6 months or more as determined by investigators according to RECIST 1.1.

    Measured: Baseline to up to two years.

  5. Duration of Remission (DOR)

    The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first).

    Measured: Baseline to up to two years.

  6. Incidence of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the National Cancer Institute standard for common toxic criteria [NCI-CTC v5.0].

    Measured: Baseline to up to two years.

  7. Severity of adverse events (AEs)

    All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the National Cancer Institute standard for common toxic reactions [NCI-CTC v5.0].

    Measured: Baseline to up to two years.

  8. Serious adverse events (SAEs)

    It refers to adverse medical events such as death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.

    Measured: Baseline to up to two years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start23 May 2023
  3. Primary completionAug 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05783921
Sponsor's protocol ID
TQB2618-AK105-Ib-02
Status last verified
Jul 2023
First submitted
8 Mar 2023
Last updated
28 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB2618 injection, Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin and Penpulimab injection, Paclitaxel, Cisplatin or Carboplatin in people with Recurrent Squamous Cell Carcinoma of the Head and Neck and Metastatic Squamous Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: Baseline to up to two years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05783921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.

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