Nasopharyngeal NeoplasmsPhase 2NCT06811844
Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC
A Phase 2 study testing Two-cycle induction chemotherapy + immunotherapy and Three-cycle induction chemotherapy + immunotherapy in people with Nasopharyngeal Neoplasms and PD-1 Inhibitor, run by The First Affiliated Hospital of Xiamen University at 3 sites in China.
Trial summary
This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, PD-1 Inhibitor, Induction Therapy
- What is being tested?
- Two-cycle induction chemotherapy + immunotherapy and Three-cycle induction chemotherapy + immunotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 3 sitesChina
- Study dates
- 25 Feb 2025to 31 Dec 2029
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old;
- Pathologically (including histology or cytology) confirmed nasopharyngeal carcinoma patients, with clinical staging T1-4N2-3M0 (according to the UICC/AJCC TNM staging system, 8th edition);
- No prior systemic treatment (surgery, radiotherapy, chemotherapy, etc.);
- At least one measurable lesion on imaging (as per RECIST criteria version 1.1);
- ECOG Performance Status (PS): 0-1;
- Expected survival ≥3 months;
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- Male subjects and women of childbearing potential must use contraception from the first dose of study medication until 24 weeks after the last dose of study medication;
- Normal major organ function, with basic normal results in hematology, biochemistry, and coagulation tests;
- The investigator believes that the treatment will provide a survival benefit.
Who cannot join
- Active, known, or suspected autoimmune disease;
- Patients with hypertension that cannot be controlled to normal range despite antihypertensive medication (systolic BP >160 mmHg, diastolic BP >90 mmHg);
- History of hereditary bleeding tendency or coagulation dysfunction. Any clinically significant bleeding symptoms within 12 weeks prior to screening, or cumulative bleeding over 50 ml in 24 hours;
- Unwell-controlled cardiac clinical symptoms or diseases;
- Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe pulmonary dysfunction;
- Active hepatitis B (HBV DNA ≥2000 IU/mL or 10^4 copies/mL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection of the assay);
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- Allergy to any of the study drugs;
- Pregnant or breastfeeding women;
- Any other factors that, in the investigator's judgment, may cause premature termination of the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hainan General Hospital
Haikou, Hainan, 570311
Shi-Ping Yang, MD, 8618976460313, shipingyang1982@163.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Dan-Ping Wang, 865922137569, xdfyec@sina.com
- Recruiting
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, 363099
Gui-Ping Chen, MD, 8613599592455, 754514055@qq.com
About this study
Official title: Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study
This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.
Read the detailed description
Currently, the recommended number of cycles for induction chemotherapy in nasopharyngeal carcinoma primarily suggests two-three cycles of induction therapy. However, several studies have found that three cycles of induction therapy did not improve patient survival and may further increase hematological toxicity and gastrointestinal toxicity compared to those treated with two cycles of induction therapy. Based on research from our center, three cycles of induction therapy also did not improve patient survival. The latest 2024 CSCO guidelines have recommended that immunotherapy can be incorporated into the induction therapy stage for locally advanced nasopharyngeal carcinoma. Therefore, based on these research findings, the investigators hypothesize that two cycles of induction chemotherapy combined with immunotherapy will not be inferior to three cycles in terms of tumor response rates and may have lower adverse reactions. The investigators aim to compare the complete response rates and long-term survival outcomes of two-cycle and three-cycle modified TPF regimens combined with camrelizumab in patients with locally advanced (T1-4N2-3M0) nasopharyngeal carcinoma, providing new options for toxicity-reduced treatment in nasopharyngeal cancer.
- Conditions
- Nasopharyngeal Neoplasms, PD-1 Inhibitor, Induction Therapy, Complete Response, Chemotherapy
- Being tested
- Two-cycle induction chemotherapy + immunotherapy, Three-cycle induction chemotherapy + immunotherapy
- Medical subject headings
- Nasopharyngeal Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-cycle induction chemotherapy + immunotherapyDrug
Also called 2
Two cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area [BSA] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA >1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.
Three-cycle induction chemotherapy + immunotherapyDrug
Also called 3
Three cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area [BSA] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA >1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Two-cycle | Experimental | Two cycles induction chemotherapy + immunotherapy Receives: Drug: Two-cycle induction chemotherapy + immunotherapy |
| Three-cycle | Active comparator | Three cycles induction chemotherapy + immunotherapy Receives: Drug: Three-cycle induction chemotherapy + immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
Complete Remission after induction therapy means that all detectable signs of the tumor have disappeared, including all measurable and assessable diseases. This includes the absence of any tumor lesions in imaging studies.
Measured: At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)
Secondary outcomes (2)
Progression-free survival
Progression-free survival was measured from the day of the NPC diagnosis until disease recurrence and death from any cause.
Measured: 3 years
Overall survival
Overall survival was measured from the day of the NPC diagnosis until death due to any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start25 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San-Gang Wu, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811844
- Sponsor's protocol ID
- XMYY-2024KY230-03
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2025
- Last updated
- 1 Jul 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06811844
- Acronym / sponsor ID
- XMYY-2024KY230-03
- Conditions
- Nasopharyngeal Neoplasms, PD-1 Inhibitor, Induction Therapy, Complete Response, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Feb 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.
This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.
Detailed description
Currently, the recommended number of cycles for induction chemotherapy in nasopharyngeal carcinoma primarily suggests two-three cycles of induction therapy. However, several studies have found that three cycles of induction therapy did not improve patient survival and may further increase hematological toxicity and gastrointestinal toxicity compared to those treated with two cycles of induction therapy. Based on research from our center, three cycles of induction therapy also did not improve patient survival. The latest 2024 CSCO guidelines have recommended that immunotherapy can be incorporated into the induction therapy stage for locally advanced nasopharyngeal carcinoma. Therefore, based on these research findings, the investigators hypothesize that two cycles of induction chemotherapy combined with immunotherapy will not be inferior to three cycles in terms of tumor response rates and may have lower adverse reactions. The investigators aim to compare the complete response rates and long-term survival outcomes of two-cycle and three-cycle modified TPF regimens combined with camrelizumab in patients with locally advanced (T1-4N2-3M0) nasopharyngeal carcinoma, providing new options for toxicity-reduced treatment in nasopharyngeal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-cycle | Experimental | Drug: Two-cycle induction chemotherapy + immunotherapyTwo cycles induction chemotherapy + immunotherapy |
| Three-cycle | Active comparator | Drug: Three-cycle induction chemotherapy + immunotherapyThree cycles induction chemotherapy + immunotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-65 years old;
- Pathologically (including histology or cytology) confirmed nasopharyngeal carcinoma patients, with clinical staging T1-4N2-3M0 (according to the UICC/AJCC TNM staging system, 8th edition);
- No prior systemic treatment (surgery, radiotherapy, chemotherapy, etc.);
- At least one measurable lesion on imaging (as per RECIST criteria version 1.1);
- ECOG Performance Status (PS): 0-1;
Key exclusion criteria (9 listed)
- Active, known, or suspected autoimmune disease;
- Patients with hypertension that cannot be controlled to normal range despite antihypertensive medication (systolic BP >160 mmHg, diastolic BP >90 mmHg);
- History of hereditary bleeding tendency or coagulation dysfunction. Any clinically significant bleeding symptoms within 12 weeks prior to screening, or cumulative bleeding over 50 ml in 24 hours;
- Unwell-controlled cardiac clinical symptoms or diseases;
- Interstitial lung disease, drug-induced pneumonia, steroid-treated radiation pneumonitis, active pneumonia with symptoms, or severe pulmonary dysfunction;
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 |
|---|---|---|
| Two-cycle induction chemotherapy + immunotherapyAlso: 2Two cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area [BSA] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA >1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle. | Drug | Two-cycle |
| Three-cycle induction chemotherapy + immunotherapyAlso: 3Three cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area [BSA] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA >1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle. | Drug | Three-cycle |
Primary outcome
Complete response
Time frame: At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)
Complete Remission after induction therapy means that all detectable signs of the tumor have disappeared, including all measurable and assessable diseases. This includes the absence of any tumor lesions in imaging studies.
2 secondary outcomes
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 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 1 Jul 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Two-cycle induction chemotherapy + immunotherapy and Three-cycle induction chemotherapy + immunotherapy in people with Nasopharyngeal Neoplasms and PD-1 Inhibitor, run by The First Affiliated Hospital of Xiamen University at 3 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 San-Gang Wu, MD (865922139531, wusg@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: At the end of Cycle 2 or Cycle 3 (each cycle is 21 days)). 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 1 Jul 2025.