TPFPhase 2NCT06781112
A Phase II Study of TPF With PD-1 Inhibitor Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg). in people with TPF and Immunotherapy, run by Weiwei Zhang at 1 site in China.
Trial summary
NPC is one of the most common malignant tumors in the head and neck region of China. Currently, the main treatment regimen for LA-NPC is radical concurrent chemoradiotherapy combined with induction or adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TPF, Immunotherapy, Nasopharyngeal Carcinoma
- What is being tested?
- albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old, ≤ 75 years old, gender not limited;
- Pathological diagnosis of nasopharyngeal non keratinizing carcinoma (differentiated or undifferentiated, i.e. WHO classification II or III);
- Stage III-IVa (8th AJCC/UICC stage), excluding T3N0-1M0 patients;
- Newly diagnosed nasopharyngeal carcinoma patients who have not received any anti-tumor treatment in the past;
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 1;
- Having sufficient organ and bone marrow function, defined as follows:
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- Blood routine: Neutrophil count (NEUT #) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 80 × 109/L; Hemoglobin ≥ 8 g/dL;
- Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN;
- Albumin ≥ 2.8 g/dL;
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR)>60 ml/min;
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5; Partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- The subjects voluntarily joined this study, signed an informed consent form, and were able to comply with the visit and related procedures specified in the protocol.
Who cannot join
- Medical history of other malignancies (except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma and other malignancies that the researchers think can be included);
- Any active autoimmune disease or autoimmune disease history, including but not limited to immune related neurological disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease, including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens Johnson syndrome (except for type I diabetes mellitus using a stable dose of insulin);
- Individuals with allergic diseases, a history of severe drug allergies, and known allergies to any component of macromolecular protein preparations or PD-1 monoclonal antibody injections (note: severe allergies may result in hospitalization);
- Received any of the following treatments:
- Patients who have previously used PD-1 antibody, PD-L1 antibody, PD-L2 antibody, CTLA-4 antibody;
- Individuals who have received anti-tumor vaccines;
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- Use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before the first administration or during the planned study period;
- Having undergone major surgery or suffered serious trauma within 4 weeks prior to the first administration of medication;
- The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss and sequelae related to previous platinum therapy neurotoxicity) or the level specified in the inclusion/exclusion criteria;
- Patients with serious medical diseases, such as Grade II and above cardiac dysfunction (NYHA standard), ischemic heart disease (such as myocardial infarction or angina pectoris), clinically significant supraventricular or ventricular arrhythmia, poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L), poorly controlled hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg), and echocardiography showed ejection fraction<50%; QTc interval, male>450 milliseconds, female>470 milliseconds; Abnormal electrocardiogram examination and researchers believe there are additional risks to the investigational drug;
- Subjects with a known history of interstitial pneumonia, a history of non infectious pneumonia, or a high suspicion of interstitial pneumonia; Or subjects who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity; Allow subjects who have previously had drug-induced or radiation non infectious pneumonia but are asymptomatic to be included in the study; Individuals with active pulmonary tuberculosis or a history of tuberculosis infection that has not been controlled through treatment;
- Patients with hyperthyroidism and organic thyroid disease cannot be included in the study. Hypothyroidism treated with stable doses of thyroid replacement hormone can be included, while hypothyroidism that can be controlled by thyroid replacement hormone treatment can be included (whether it can be controlled will be confirmed by the researcher and/or endocrinologist);
- Presence of active infection, or unexplained fever occurring during screening or 48 hours prior to initial administration, or use of systemic antibiotics within one week prior to signing informed consent;
- Active hepatitis B (HBV DNA ≥ 2000 IU/ml or 104 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCV RNA higher than the detection limit of the analytical method), or a known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
- Having a clear history of neurological or mental disorders, such as epilepsy or dementia;
- Have a clear history of drug abuse or alcohol abuse within the past 3 months;
- Pregnant or lactating women; The subjects (and their partners) have planned to have children, engaged in unprotected sexual activity, or are unwilling to use appropriate contraceptive measures (such as condoms, contraceptive rings, or partner sterilization) during the screening period until 3 months after the end of their study;
- Received any investigational drug within 4 weeks prior to the first use of the investigational drug, or enrolled in another clinical study at the same time, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
- The researchers determined that there may be other factors affecting the subjects in this study, which may prevent them from completing the trial medication and follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chengdu University of Traditional Chinese Medicine Second Clinical School/Affiliated Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Weiwei Zhang, phD, +8602861719580, 743244517@qq.com
About this study
Official title: Prospective, Single Center, Single Arm Phase II Clinical Study of TPF Combined With Immune Checkpoint Inhibitor Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma Patients
NPC is one of the most common malignant tumors in the head and neck region of China. Currently, the main treatment regimen for LA-NPC is radical concurrent chemoradiotherapy combined with induction or adjuvant chemotherapy. However, after radical radiotherapy and chemotherapy treatment, 15% -30% of patients still experience recurrence or distant metastasis. At present, the treatment options for R/M-NPC are very limited, especially for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed second-line treatment, there is no standard treatment plan. Therefore, it is urgent to study a new treatment mode to improve the therapeutic efficacy of LA-NPC, thereby reducing the recurrence and metastasis rates.
This study explores the safety and efficacy of TPF combined with immune checkpoint inhibitor induction therapy in LA-NPC patients through prospective research. The results of this study are expected to provide new ideas and methods for the treatment of LA-NPC and provide reference for clinical practice. The investigators believe that induction chemotherapy combined with immunotherapy has broad application prospects in the field of LA-NPC, and is expected to bring better treatment effects and quality of life to patients, bringing new hope to the medical community and patients.
Read more
According to the inclusion criteria, eligible patients will be included:
Induction chemotherapy with Tislelizumab combined with TPF regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor (Tislelizumab 200mg).
All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with Tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined. The IMRT radiotherapy area includes the primary tumor volume (GTVp), the total tumor volume of the affected lymph nodes (GTVn), the high-risk clinical target volume (CTV1), and the low-risk clinical target volume (CTV2). PTVp, PTV1, and PTV2 are respectively expanded by 3mm on GTVp, CTV1, and CTV2. The prescription doses for PTVp, PTVn, PTV1, and PTV2 are 70-72 Gy, 66-70 Gy, 60-68 Gy, and 54-58 Gy, respectively, with a total of 30-33 divided exposures.
After the completion of synchronous radiotherapy and chemotherapy, adjuvant therapy with Tislelizumab (Tislelizumab 200mg d1, once every 3 weeks, for a total of 8 courses) is administered. For patients with high-risk recurrence factors (T4 or N2), combination chemotherapy with capecitabine 625mg/m2 po bid is performed for one year.
Treat until any of the following conditions occur:
Disease progression; No clinical benefit; Intolerable toxicity; Withdrawal of informed consent; Or maintain treatment for up to six months.
- Conditions
- TPF, Immunotherapy, Nasopharyngeal Carcinoma, Phase II Clinical Study
- Being tested
- albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg).
- Keywords
- TPF, Immunotherapy, Nasopharyngeal Carcinoma, phase II clinical study
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg).Drug
Also called radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatment
Induction chemotherapy with PD-1 inhibitor combined with TPF regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor ( 200mg).
All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined.
| Study group | Role | What they receive |
|---|---|---|
| TPF combined with immunotherapy for LA-NPC | Experimental | Induction chemotherapy with PD-1 inhibitor combined with TPF (albumin paclitaxel, cisplatin and 5-fluorouracil) regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor ( 200mg).All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined. Receives: Drug: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg). |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Proportion of patients with complete remission (CR) and partial remission (PR)
Measured: From enrollment to the end of 3 cycles (each cycle is 21 days) introduction therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- TPF induction chemotherapy combined with tislelizumab+cisplatin concurrent chemoradiotherapy combined with tislelizumab adjuvant therapy (experimental group): TPF induction chemotherapy (albumin paclitaxel 200mg/m2+cisplatin 60mg/m2, divided into 3 days of infusion+5-fluorouracil 3000mg/m2, continuously intravenously pumped for 120 hours)+trastuzumab 200mg d1, once every 3 weeks, for a total of 3 courses+concurrent chemoradiotherapy combined with tislelizumab (cisplatin 100mg/m2+tislelizumab 200mg, starting from the first day of radiotherapy, once every 3 weeks during radiotherapy, for a total of 3 courses), synchronous IMRT+tislelizumab adjuvant therapy (tislelizumabb 200mg d1, once every 3 weeks) (8 trips in total)
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weiwei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weiwei Zhang, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781112
- Sponsor's protocol ID
- ethical2024-079(Science)-01
- Other IDs
- 2024276
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Center, Single Arm Phase II Clinical Study of TPF Combined With Immune Checkpoint Inhibitor Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma Patients
- ClinicalTrials.gov ID
- NCT06781112
- Acronym / sponsor ID
- ethical2024-079(Science)-01
- Conditions
- TPF, Immunotherapy, Nasopharyngeal Carcinoma, Phase II Clinical Study
- Keywords
- TPF, Immunotherapy, Nasopharyngeal Carcinoma, phase II clinical study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Weiwei ZhangUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NPC is one of the most common malignant tumors in the head and neck region of China. Currently, the main treatment regimen for LA-NPC is radical concurrent chemoradiotherapy combined with induction or adjuvant chemotherapy. However, after radical radiotherapy and chemotherapy treatment, 15% -30% of patients still experience recurrence or distant metastasis. At present, the treatment options for R/M-NPC are very limited, especially for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed second-line treatment, there is no standard treatment plan. Therefore, it is urgent to study a new treatment mode to improve the therapeutic efficacy of LA-NPC, thereby reducing the recurrence and metastasis rates.
This study explores the safety and efficacy of TPF combined with immune checkpoint inhibitor induction therapy in LA-NPC patients through prospective research. The results of this study are expected to provide new ideas and methods for the treatment of LA-NPC and provide reference for clinical practice. The investigators believe that induction chemotherapy combined with immunotherapy has broad application prospects in the field of LA-NPC, and is expected to bring better treatment effects and quality of life to patients, bringing new hope to the medical community and patients.
According to the inclusion criteria, eligible patients will be included:
Induction chemotherapy with Tislelizumab combined with TPF regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor (Tislelizumab 200mg).
All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with Tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined. The IMRT radiotherapy area includes the primary tumor volume (GTVp), the total tumor volume of the affected lymph nodes (GTVn), the high-risk clinical target volume (CTV1), and the low-risk clinical target volume (CTV2). PTVp, PTV1, and PTV2 are respectively expanded by 3mm on GTVp, CTV1, and CTV2. The prescription doses for PTVp, PTVn, PTV1, and PTV2 are 70-72 Gy, 66-70 Gy, 60-68 Gy, and 54-58 Gy, respectively, with a total of 30-33 divided exposures.
After the completion of synchronous radiotherapy and chemotherapy, adjuvant therapy with Tislelizumab (Tislelizumab 200mg d1, once every 3 weeks, for a total of 8 courses) is administered. For patients with high-risk recurrence factors (T4 or N2), combination chemotherapy with capecitabine 625mg/m2 po bid is performed for one year.
Treat until any of the following conditions occur:
Disease progression; No clinical benefit; Intolerable toxicity; Withdrawal of informed consent; Or maintain treatment for up to six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TPF induction chemotherapy combined with tislelizumab+cisplatin concurrent chemoradiotherapy combined with tislelizumab adjuvant therapy (experimental group): TPF induction chemotherapy (albumin paclitaxel 200mg/m2+cisplatin 60mg/m2, divided into 3 days of infusion+5-fluorouracil 3000mg/m2, continuously intravenously pumped for 120 hours)+trastuzumab 200mg d1, once every 3 weeks, for a total of 3 courses+concurrent chemoradiotherapy combined with tislelizumab (cisplatin 100mg/m2+tislelizumab 200mg, starting from the first day of radiotherapy, once every 3 weeks during radiotherapy, for a total of 3 courses), synchronous IMRT+tislelizumab adjuvant therapy (tislelizumabb 200mg d1, once every 3 weeks) (8 trips in total)
| Arm | Type | Receives |
|---|---|---|
| TPF combined with immunotherapy for LA-NPC | Experimental | Drug: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg).Induction chemotherapy with PD-1 inhibitor combined with TPF (albumin paclitaxel, cisplatin and 5-fluorouracil) regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor ( 200mg).All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old, ≤ 75 years old, gender not limited;
- Pathological diagnosis of nasopharyngeal non keratinizing carcinoma (differentiated or undifferentiated, i.e. WHO classification II or III);
- Stage III-IVa (8th AJCC/UICC stage), excluding T3N0-1M0 patients;
- Newly diagnosed nasopharyngeal carcinoma patients who have not received any anti-tumor treatment in the past;
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 1;
Key exclusion criteria (19 listed)
- Medical history of other malignancies (except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma and other malignancies that the researchers think can be included);
- Any active autoimmune disease or autoimmune disease history, including but not limited to immune related neurological disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease, including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens Johnson syndrome (except for type I diabetes mellitus using a stable dose of insulin);
- Individuals with allergic diseases, a history of severe drug allergies, and known allergies to any component of macromolecular protein preparations or PD-1 monoclonal antibody injections (note: severe allergies may result in hospitalization);
- Received any of the following treatments:
- Patients with serious medical diseases, such as Grade II and above cardiac dysfunction (NYHA standard), ischemic heart disease (such as myocardial infarction or angina pectoris), clinically significant supraventricular or ventricular arrhythmia, poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L), poorly controlled hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg), and echocardiography showed ejection fraction<50%; QTc interval, male>450 milliseconds, female>470 milliseconds; Abnormal electrocardiogram examination and researchers believe there are additional risks to the investigational drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg).Also: radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatmentInduction chemotherapy with PD-1 inhibitor combined with TPF regimen, administered every 3 weeks: albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and PD-1 inhibitor ( 200mg). All patients received 3 cycles of induction therapy followed by radical concurrent chemoradiotherapy combined with tislelizumab (200mg) treatment, Q3W. The cisplatin in the synchronous chemoradiotherapy regimen is administered once a week, with a dose of 40mg/m2 per dose, and the total dose of cisplatin does not exceed 100mg/m2. For patients who cannot tolerate cisplatin during synchronous radiotherapy and chemotherapy, cisplatin may not be combined. | Drug | TPF combined with immunotherapy for LA-NPC |
Primary outcome
objective response rate
Time frame: From enrollment to the end of 3 cycles (each cycle is 21 days) introduction therapy
Proportion of patients with complete remission (CR) and partial remission (PR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- National Health Security Information Platform Medical Research Registration and Filing Information SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
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Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC
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RecruitingPhase 2
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Nasopharyngeal Neoplasms, PD-1 Inhibitor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing albumin paclitaxel (200mg/m2), cisplatin (60mg/m2, infused over 3 days), 5-fluorouracil (3000mg/m2, continuously intravenously pumped for 120 hours), and tislelizumab ( 200mg). in people with TPF and Immunotherapy, run by Weiwei Zhang at 1 site 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 12 inclusion and 19 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: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Zhang, PhD (+8602861719580, 743244517@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: From enrollment to the end of 3 cycles (each cycle is 21 days) introduction therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2025.