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Nasopharyngeal CarcinomaPhase 2NCT05563480

TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection and TQB2618 injection; Penpulimab injection in people with Nasopharyngeal Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study consists of two parts: Part 1 encompasses a safety lead - in phase and an expansion phase. In both phases, subjects with advanced nasopharyngeal carcinoma who have previously failed platinum - based chemotherapy and immune checkpoint inhibitors (such as anti - PD - 1 monoclonal antibodies/anti - PD - L1… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection and TQB2618 injection; Penpulimab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
5 sitesChina
Study dates
27 Oct 2022to 28 May 2025
Phase
Phase 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

  • Histologically or cytologically confirmed nasopharyngeal carcinoma, stage IVb as defined by the AJCC TNM staging system for nasopharyngeal carcinoma, 8th edition in 2017 or subjects with recurrent nasopharyngeal carcinoma who were not suitable for local therapy (For neoadjuvant/adjuvant therapy and radical concurrent chemoradiotherapy, if the disease progresses during treatment or within 6 months after the treatment completion, it should be counted as a failure of first-line treatment of the original plan, and if it exceeds 6 months, it cannot be counted as first-line treatment failure. Alterations of treatment regimen due to drug intolerance are not defined as treatment failure).
  • The first part of enrolled patients shall also meet the following requirements:
  • At least received first-line treatment for recurrent/metastatic lesions, and the last anti-tumor treatment before enrollment had evidence of imaging progress in line with RECIST 1.1 standard;
  • At least have received platinum containing chemotherapy and immunocheckpoint inhibitors (anti-PD-1 monoclonal antibody/anti-PD-L1 monoclonal antibody, etc.) in the past and failed treatment, and there is evidence of imaging progress that meets the RECIST 1.1 standard. Platinum containing chemotherapy and immunotherapy can be used during palliative treatment for recurrent/metastatic lesions, or during radical treatment for locally advanced diseases.
  • Immunotherapy for recurrent/metastatic lesions shall not exceed 2 lines (For neoadjuvant/adjuvant therapy and radical concurrent chemoradiotherapy, if the disease progresses during treatment or within 6 months after the treatment completion, it should be counted as a failure of first-line treatment of the original plan, and if it exceeds 6 months, it cannot be counted as first-line treatment. Failure. Alterations of treatment regimen due to drug intolerance do not defined as treatment failure
  • For the latest immunotherapy before enrollment, if it is aimed at recurrence/metastasis, the best efficacy is at least SD (≥ 6 weeks) or confirmed PR or immunotherapy duration ≥ 12 weeks.
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  • The second part of the enrolled patients also need to meet the following requirements:
  • Have not received systemic antitumor therapy for recurrent/metastatic nasopharyngeal carcinoma before;
  • No previous treatment with immune checkpoint inhibitors (anti PD-1 monoclonal antibody/anti PD-L1 monoclonal antibody, etc.). Those who have used no more than one immune checkpoint inhibitor (limited to CTLA-4/PD-1/PD-L1 monoclonal antibody, not including bispecific antibody, not including Penpulimab injection) in the stage of locally advanced radical treatment can be included if they meet the following criteria:
  • If used in the induction phase (with or without other drugs), the best effect in the induction phase is at least PR;
  • If used during radical radiochemotherapy/radiotherapy or subsequent maintenance stage, there is no progress during treatment and within one year after stopping treatment
  • At least one measurable lesion confirmed according to RECIST 1.1 criteria;
  • The function of main organs are well and meet the following standards:
  • Routine Blood routine examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before the examination):
  • Hemoglobin (HGB) ≥90 g/L;
  • Absolute value of neutrophil (NEUT) ≥1.5×109/L;
  • Platelets count (PLT) ≥ 100×109/L.
  • The biochemical examination shall meet the following standards:
  • Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) (Patients with Gilbert syndrome ≤ 3 × ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If it is accompanied by liver metastasis, ALT and AST ≤ 5 × ULN;
  • Serum creatinine (CR) ≤ 1.5 × ULN or Creatinine clearance (CCR) ≥ 60 ml/min;
  • Blood coagulation function or thyroid function test should meet the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR)≤1.5×ULN (no anticoagulant therapy);
  • Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, it can be selected.
  • Heart color Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
  • Female subjects of reproductive age should agree that they must conduct contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during and for 6 months after the study; Female subjects should have a negative serum/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Male subjects should agree that they must conduct contraception during the study period and for 6 months after the study.

Who cannot join

  • Combined diseases and medical history:
  • Other malignant tumors have occurred or are currently suffering from other malignant tumors within 5 years before the first medication, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma;
  • Unresolved toxicities greater than CTC AE grade 1 due to any prior therapy, excluding alopecia, neurotoxic sequelae associated with prior platinum therapy;
  • Received major surgical treatment, obvious traumatic injury (excluding needle biopsy, endoscopic biopsy, etc.) within 28 days before the first drug;
  • Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before the first drug;
  • Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms;
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  • Cancer-related symptoms and treatment:
  • Received NMPA-approved Chinese patent medicines with anti-tumor indications in the drug insert within 2 weeks prior to the first administration;
  • Received surgery, chemotherapy, radiotherapy or other anti-cancer therapy within 3 weeks before the start of study treatment (the washout period is calculated from the end of the last treatment); those who have received local radiotherapy in the past can be enrolled if they meet the following conditions: radiotherapy The end of the study treatment is more than 3 weeks (more than 2 weeks for brain radiotherapy); and the target lesions selected in this study are not in the radiotherapy area; Or the target lesion is located in the radiotherapy area, but the progress has been confirmed.
  • Previous treatment with anti-TIM-3 antibodies;
  • The nasopharyngeal lesions recurred after radiotherapy and received Re-radiotherapy;
  • maging (CT or MRI) shows that the tumor has invaded around important blood vessels, and it is judged by the investigator that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  • Known uncontrolled or symptomatic active central nervous system (CNS) metastases presenting with clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth. Patients with a history of CNS metastases or spinal cord compression were eligible if they were clearly treated and clinically stable after 4 weeks of discontinuation of anticonvulsants, steroids, or dehydrating agents prior to the first dose of the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410078

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510100

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530012

  • Union Hospital Tongji Medical College, Huazhong University Of Science And Technology

    Wuhan, Hubei, 430022

  • The Fifth Affiliated Hospital Sun Yat sen University

    Zhuhai, Guangdong, 519000

Other trials in China

About this study

Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

This study consists of two parts:

Part 1 encompasses a safety lead - in phase and an expansion phase. In both phases, subjects with advanced nasopharyngeal carcinoma who have previously failed platinum - based chemotherapy and immune checkpoint inhibitors (such as anti - PD - 1 monoclonal antibodies/anti - PD - L1 monoclonal antibodies, etc.) will be enrolled. The treatment regimen is TQB2618 combined with penpulimab. During the safety lead - in phase, it is to explore whether two dosage groups of TQB2618 in combination with penpulimab (1200mg/1500mg) are safe and tolerable. If both dosage groups are tolerable, in the expansion phase, an additional 18 to 24 subjects will be enrolled to receive TQB2618 (1500mg) + penpulimab (200mg). If the high dosage (1500mg) of TQB2618 is not tolerated, all subjects will receive TQB2618 (1200mg) + penpulimab (200mg).

Read more

Part 2 also includes a safety lead - in phase and an expansion phase. It enrolls treatment - naïve subjects with advanced nasopharyngeal carcinoma who have not received prior systemic treatment. These subjects will receive TQB2618 + penpulimab + GP chemotherapy, with the dosage of TQB2618 being 1200mg. In the safety lead - in phase, 3 to 6 subjects will be enrolled. If the treatment combination is safe and tolerable, then in the expansion phase, an additional 24 to 27 subjects will be enrolled.

Both parts of the study will be carried out simultaneously

Being tested
TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection, TQB2618 injection; Penpulimab injection
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride InjectionDrug

    TQB2618 injection: Anti-TIM-3 monoclonal antibody; Penpulimab injection: Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

    Cisplatin: Damages DNA structure Gemcitabine hydrochloride: Interferes with DNA synthesis;

  • TQB2618 injection; Penpulimab injectionDrug

    TQB2618 injection: Anti-TIM-3 monoclonal antibody; Penpulimab injection: Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

Study groups in NCT05563480
Study groupRoleWhat they receive
TQB2618+Pempulimab+ChemotherapyExperimentalInduction therapy: TQB2618 injection + Penpulimab injection + Gemcitabine hydrochloride injection + cisplatin injection; Maintenance treatment: TQB2618 injection +Penpulimab injection; 21 days as a treatment cycle.
Receives: Drug: TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection
TQB2618+PempulimabExperimentalTQB2618 injection combined with Penpulimab injection, 21 days as a treatment cycle.
Receives: Drug: TQB2618 injection; Penpulimab injection

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    It refers to serious toxic reactions that occur within the first treatment cycle and are considered unacceptable.

    Measured: Baseline up to 3 weeks

  2. Objective Response Rate

    It is generally defined as complete response plus partial response.

    Measured: Up to 60 weeks

  3. Progression-free Survival

    The period between the beginning of treatment and the observation of disease progression or death from any cause in a patient with a tumor disease.

    Measured: Up to 60 weeks

Secondary outcomes (5)

  1. Overall Survival

    From drug use to the time of death from any cause.

    Measured: Baseline up to 100 weeks

  2. Duration Of Response

    It is the efficacy evaluation index of tumor response, which refers to the time from the first evaluation of tumor as complete response (CR) or partial response (PR) to the first evaluation of disease progression (PD) or death from any cause.

    Measured: 24 weeks

  3. Disease Control Rate

    It is the proportion of patients whose tumors have shrunk or stabilized for a certain amount of time and includes complete response (CR), partial response (PR), and stable (SD) cases.

    Measured: Baseline up to 96 weeks

  4. Adverse Events

    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.

    Measured: Baseline up to 100 weeks

  5. Serious Adverse Event

    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 up to 100 weeks

Timeline

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

  1. First posted3 Oct 2022
  2. Study start27 Oct 2022
  3. Primary completion28 May 2025
  4. Study completion28 May 2025

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563480
Sponsor's protocol ID
TQB2618-AK105-II-01
Status last verified
Oct 2022
First submitted
27 Sep 2022
Last updated
7 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu C, Wang SY, Nie M, Yang KY, Huang XQ, Qu S, Chen H, Shen LF, Huang J, Zhang F, Peng YP, Shi LL, Hong XH, Zhang ZJ, Tang LL, Guo L, Ouyang PY, Gao JM, Mao YP, Huang Y, Guo R, Liu LZ, Tian L, Li HJ, Li JB, Ma J, Xia Y, Cai QQ. TQB2618 plus penpulimab, alone or in combination with chemotherapy, for recurrent or metastatic nasopharyngeal carcinoma: a multicentre, two-cohort, phase 2 trial. Clin Cancer Res. 2026 Jun 10. doi: 10.1158/1078-0432.CCR-26-0347. Online ahead of print.

    PubMed 42268339

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection and TQB2618 injection; Penpulimab injection in people with Nasopharyngeal Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 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 25 inclusion and 14 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Baseline up to 3 weeks). The study lists 3 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 NCT05563480, which also lists 1 linked publication.

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 7 Apr 2026.

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