Nasopharyngeal CarcinomaPhase 2/3NCT05433597
A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for LA-NPC
A Phase 2/3 study testing 5-fu, Cisplatin and Radiotherapy in people with Nasopharyngeal Carcinoma and TNF, run by Sun Yat-sen University.
Trial summary
Based on the application prospect of rmh-TNF combined with chemotherapy in the treatment of solid tumors. In this study, cisplatin combined with low dose 5-FU was proposed to enhance the immune function of 5-FU. Tianenfu is a novel recombinant modified human tumor necrosis with high activity and low toxicity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, TNF, Chemo-radiotherapy
- What is being tested?
- 5-fu, Cisplatin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jul 2029
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥18 years old and ≤60 years old;
- Pathologically confirmed nasopharyngeal carcinoma;
- Patients with primary locally advanced non-metastatic nasopharyngeal carcinoma who were eligible for standard concurrent radiotherapy and chemotherapy were in line with stage III and IVA defined by the International Union against Cancer and American Joint Commission on Cancer (UICC/AJCC) staging System (version 8) (note: Stage III only included EBV-DNA>1×10^4 copy/mL).
- Patients with locally advanced nasopharyngeal carcinoma who have not received prior radiotherapy or chemotherapy for the disease in this study;
- Karnofsky functional status score should be at least 70 points (the decline of functional status score caused by tumor should be appropriately relaxed after the judgment of the researcher, and the minimum score should be no less than 50 points. );
- At least 1 measurable lesion according to RECIST1.1 assessment criteria, measurable lesion should not have received local treatment such as radiotherapy;
Show all 15Show fewer
- Expected survival ≥3 months;
- The function of vital organs meets the following requirements (not allowed within 14 days before screening . May use any blood components, cell growth factors, leukoplast, platelets Drugs, anemia correction drugs) :
- Neutrophil absolute count (ANC) ≥1.5×109/L
- Platelet ≥100×109/L;
- Hemoglobin ≥8.0g/ dL (note: Hemoglobin ≥8.0g/ dL can be achieved through blood transfusion or other intervention);
- Serum albumin ≥2.8g/dL;
- Bilirubin ≤ 1.5x ULN, ALT and AST≤ 1.5x ULN; ALT and AST≤ 5x ULN if liver metastasis was present;
- creatinine clearance ≥50mL/min
- Women of non-surgical sterilization or reproductive age and sexually active men enrolled in the study are required to use a medically effective form of contraception (such as an intrauterine device [IUD], birth control pills or condoms) for the duration of the study treatment and for at least 3 months after the last use of Tamfu and for at least 6 months after the last use of chemotherapy; The serum or urine HCG test of female patients of reproductive age who were not undergoing surgical sterilization must be negative within 7 days prior to study enrollment. And must be non lactation period; 10 Informed consent has been signed. -
Who cannot join
- Have a history of allergy to 5-FU, cisplatin and tumor necrosis factor;
- Previous treatment related to tumor necrosis factor (TNF);
- Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to randomization or major surgery was expected during the study period;
- The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded);
- Subject is taking immunosuppressants, or systemic, or absorbable sites Hormone therapy to achieve immunosuppression (dose >10mg/ day prednisone or Other equally effective hormones) and continued to be used within 2 weeks prior to enrollment.
- The subject has previous or co-existing malignancies (except those that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid);
Show all 13Show fewer
- Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: ① HEART failure of NYHA grade 2 or above ② unstable angina pectoris ③ myocardial infarction within 1 year ⑤ clinically significant ventricular arrhythmias or ventricular arrhythmias requiring treatment or intervention;
- Subjects have active infection or have unexplained fever >38.5 degrees during screening but before the first dose (the investigator judged that the subjects' fever due to tumor could be included in the study);
- Subjects with congenital or acquired immune deficiency (e.g. HIV infected), or active hepatitis (reference: HBsAg, anti-HBS, HBeAg, anti-HBC, anti-HBE, HBV DNA≥10⁴/ml, liver cell transaminase, etc.); Hepatitis C reference: HCV antibodies and HCVRNA);
- The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse;
- In the judgment of the researcher, the subject has other factors that may lead to the termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory examination, family or social factors, which may affect the safety of the subject, or the collection of test data and samples.
- Women who are pregnant or breastfeeding, or who refuse/cannot accept medically acceptable conditions. For women with potential pregnancy and sexually active men.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for Local-advancedNPC
Based on the application prospect of rmh-TNF combined with chemotherapy in the treatment of solid tumors. In this study, cisplatin combined with low dose 5-FU was proposed to enhance the immune function of 5-FU. Tianenfu is a novel recombinant modified human tumor necrosis with high activity and low toxicity. The fact that RMH-TNF has the potential of better in vivo efficacy and clinical antitumor effect. Therefore, the study was designed to investigate the treatment of concurrent chemoradiotherapy combined with TNF versus concurrent chemoradiotherapy combined with placebo for the efficacy and safety of advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma, TNF, Chemo-radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fuDrug
5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.
CisplatinDrug
Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle.
RadiotherapyRadiation
Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy . GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks.
TNFDrug
TNF (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intramuscular, QD, 30 days in the first and third months, once a day.
PlaceboDrug
Placebo: 1-2ml normal saline, intramuscular injection, QD, once a day, 30 days in the first and third months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Chemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 2 cycles, a total of 4 months.
Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks.
Placebo: Normal saline 1-2ml, intramuscular injection, QD, 30 days in the first and third months, once a day. Receives: Drug: 5-fu; Drug: Cisplatin; Radiation: Radiotherapy; Drug: Placebo |
| Experimental group | Active comparator | Chemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 2 cycles, a total of 4 months.
Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks.
Tianenfu (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intrascularization, QD, 30 days in the first and third months, once a day. Receives: Drug: 5-fu; Drug: Cisplatin; Radiation: Radiotherapy; Drug: TNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival
Measured: Up to 5 years
PFS
Progression-free survival
Measured: Up to 5 years
Severe drug-related adverse events
grade III-V according to CTCAE v4.0
Measured: Up to 2 approximately years
Secondary outcomes (4)
ORR
Objective response rate
Measured: Up to 2 approximately years
DCR
Disease control rate
Measured: Up to 2 approximately years
DOR
Duration of response
Measured: Up to 2 approximately years
Drug-related adverse events grade I-II
Minor drug-related adverse events grade I-II according to CTCAE v4.0
Measured: Up to 2 approximately years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Weike Bioscience Co., Ltd.
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433597
- Sponsor's protocol ID
- 2021-FXY-422
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- 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 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for Local-advancedNPC
- ClinicalTrials.gov ID
- NCT05433597
- Acronym / sponsor ID
- 2021-FXY-422
- Conditions
- Nasopharyngeal Carcinoma, TNF, Chemo-radiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shanghai Weike Bioscience Co., Ltd.
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 27 Jun 2022 (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.
Based on the application prospect of rmh-TNF combined with chemotherapy in the treatment of solid tumors. In this study, cisplatin combined with low dose 5-FU was proposed to enhance the immune function of 5-FU. Tianenfu is a novel recombinant modified human tumor necrosis with high activity and low toxicity. The fact that RMH-TNF has the potential of better in vivo efficacy and clinical antitumor effect. Therefore, the study was designed to investigate the treatment of concurrent chemoradiotherapy combined with TNF versus concurrent chemoradiotherapy combined with placebo for the efficacy and safety of advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: 5-fu, Drug: Cisplatin, Radiation: Radiotherapy, Drug: PlaceboChemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 2 cycles, a total of 4 months. Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks. Placebo: Normal saline 1-2ml, intramuscular injection, QD, 30 days in the first and third months, once a day. |
| Experimental group | Active comparator | Drug: 5-fu, Drug: Cisplatin, Radiation: Radiotherapy, Drug: TNFChemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 2 cycles, a total of 4 months. Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks. Tianenfu (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intrascularization, QD, 30 days in the first and third months, once a day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- ≥18 years old and ≤60 years old;
- Pathologically confirmed nasopharyngeal carcinoma;
- Patients with primary locally advanced non-metastatic nasopharyngeal carcinoma who were eligible for standard concurrent radiotherapy and chemotherapy were in line with stage III and IVA defined by the International Union against Cancer and American Joint Commission on Cancer (UICC/AJCC) staging System (version 8) (note: Stage III only included EBV-DNA>1×10^4 copy/mL).
- Patients with locally advanced nasopharyngeal carcinoma who have not received prior radiotherapy or chemotherapy for the disease in this study;
- Karnofsky functional status score should be at least 70 points (the decline of functional status score caused by tumor should be appropriately relaxed after the judgment of the researcher, and the minimum score should be no less than 50 points. );
Key exclusion criteria (13 listed)
- Have a history of allergy to 5-FU, cisplatin and tumor necrosis factor;
- Previous treatment related to tumor necrosis factor (TNF);
- Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to randomization or major surgery was expected during the study period;
- The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded);
- Subject is taking immunosuppressants, or systemic, or absorbable sites Hormone therapy to achieve immunosuppression (dose >10mg/ day prednisone or Other equally effective hormones) and continued to be used within 2 weeks prior to enrollment.
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 |
|---|---|---|
| 5-fu5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle. | Drug | Control group, Experimental group |
| CisplatinCisplatin: 80mg/m2, used on the 1st and 28th day of each cycle. | Drug | Control group, Experimental group |
| RadiotherapyRadiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy . GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks. | Radiation | Control group, Experimental group |
| TNFTNF (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intramuscular, QD, 30 days in the first and third months, once a day. | Drug | Experimental group |
| PlaceboPlacebo: 1-2ml normal saline, intramuscular injection, QD, once a day, 30 days in the first and third months. | Drug | Control group |
Primary outcome
OS
Time frame: Up to 5 years
Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival Overall survival
PFS
Time frame: Up to 5 years
Progression-free survival
Severe drug-related adverse events
Time frame: Up to 2 approximately years
grade III-V according to CTCAE v4.0
4 secondary outcomes
ORR
Time frame: Up to 2 approximately years
DCR
Time frame: Up to 2 approximately years
DOR
Time frame: Up to 2 approximately years
Drug-related adverse events grade I-II
Time frame: Up to 2 approximately years
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 27 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Yun-fei Xia, MD principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5-fu, Cisplatin and Radiotherapy in people with Nasopharyngeal Carcinoma and TNF, run by Sun Yat-sen University.
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 15 inclusion and 13 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yun-fei Xia, MD (+8613602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Up to 5 years). 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?
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 27 Jun 2022.