Nasopharyngeal CarcinomaPhase 3NCT06486220
PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPC,a Phase III ,Open, Randomized Clinical Trial.
A Phase 3 study testing Intestinal bacteria freeze-dried powder capsules in people with Nasopharyngeal Carcinoma, run by Yun-fei Xia.
Trial summary
There is a correlation between gut microbiota and immunotherapy reactivity, and regulating gut microbiota through FMT can prevent primary resistance to immune checkpoint inhibitors and further improve the effectiveness of tumor immunotherapy.Therefore, on the basis of previous studies, this study intends to explore… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Intestinal bacteria freeze-dried powder capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old;
- Pathological diagnosis of nasopharyngeal carcinoma;
- Patients diagnosed with oligometastatic nasopharyngeal carcinoma who meet stage IVb as defined by the International Union against Cancer and the American Joint Committee on Cancer (UICC/AJCC) staging System (8th edition) (Oligometastatic as ≤3 organs and ≤5 sites of metastasis);
- Patients with metastatic nasopharyngeal carcinoma who had not previously received systematic chemotherapy for the disease in this study, except neoadjuvant chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy received 6 months before the first administration;
- Karnofsky's functional status score should be at least 70 points (if the functional status score is decreased due to tumor, it should be appropriately relaxed after the researchers' judgment, and the minimum score should be no less than 50 points, as shown in Annex I);
- According to the RECIST1.1 evaluation criteria, there should be at least 1 measurable lesion, and the measurable lesion should not have received local treatment such as radiotherapy;
- Expected survival ≥3 months;
- A tolenrant organs.
Who cannot join
- allergy to 5-FU, gemcitabine, cisplatin, other monoclonal antibodies, or any component of triplimab
- Prior treatment with PD-1 receptor or its ligand PD-L1 or cytotoxic T lymphocyte-associated protein 4 (CTLA4) receptor;
- Had major surgery other than diagnosis of nasopharyngeal cancer within 28 days prior to randomization or was expected to require major surgery during the study period;
- Patients with severe damage of intestinal barrier such as sepsis, active massive bleeding of digestive tract and perforation due to various reasons;
- Currently diagnosed with fulminant colitis or toxic megacolon;
- Enteral nutrition patients who cannot tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula, etc.;
- patients with any active autoimmune disease or a history of autoimmune diseases.
About this study
There is a correlation between gut microbiota and immunotherapy reactivity, and regulating gut microbiota through FMT can prevent primary resistance to immune checkpoint inhibitors and further improve the effectiveness of tumor immunotherapy.Therefore, on the basis of previous studies, this study intends to explore whether intestinal flora transplantation can improve the anti-tumor efficacy of low-dose long term 5-FU pumping ("old fire soup") therapy combined with immunotherapy and reduce the occurrence of toxic side effects in patients with metastatic nasopharyngeal carcinoma.
Read the detailed description
Experimental group (PFLL + PD-1 + FMT) :
5-Fu 200mg/ m2 /d, D1-30 + cisplatin 80mg/ m2, d1, 28 or D1-3, 28-30 + triplizumab 240mg, d1, 22 + FMT 10 capsules in the morning, middle and evening, D-5-3, 11-13, 38-40;Every 60 days/cycle, PFLL + PD-1 + FMT is given for a maximum of 6 cycles.
Control group (PFLL + PD-1) :
5-Fu 200mg/ m2 /d, D1-30 + cisplatin 80mg/ m2, d1, 28 or D1-3, 28-30 + triplizumab 240mg, d1, 22;PFLL + PD-1 is given a maximum of 6 cycles per 60 days/cycle.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Intestinal bacteria freeze-dried powder capsules
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal bacteria freeze-dried powder capsulesDrug
Also called 5-FU+DDP+anti-PD-1 mAb
Oral healthy intestinal bacteria freeze-dried powder capsules, tid
| Study group | Role | What they receive |
|---|---|---|
| Flora Transplantation group | Experimental | 5-Fu+DDP+anti-PD-1 mAb+FMT Receives: Drug: Intestinal bacteria freeze-dried powder capsules |
| Control group | No intervention | 5-Fu+DDP+anti-PD-1 mAb |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 1-year PFS 40%
Secondary outcomes (1)
OS
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun-fei Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun-fei Xia, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486220
- Sponsor's protocol ID
- 2023-FXY-120
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPC,a Phase III ,Open, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06486220
- Acronym / sponsor ID
- 2023-FXY-120
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Yun-fei XiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
There is a correlation between gut microbiota and immunotherapy reactivity, and regulating gut microbiota through FMT can prevent primary resistance to immune checkpoint inhibitors and further improve the effectiveness of tumor immunotherapy.Therefore, on the basis of previous studies, this study intends to explore whether intestinal flora transplantation can improve the anti-tumor efficacy of low-dose long term 5-FU pumping ("old fire soup") therapy combined with immunotherapy and reduce the occurrence of toxic side effects in patients with metastatic nasopharyngeal carcinoma.
Detailed description
Experimental group (PFLL + PD-1 + FMT) :
5-Fu 200mg/ m2 /d, D1-30 + cisplatin 80mg/ m2, d1, 28 or D1-3, 28-30 + triplizumab 240mg, d1, 22 + FMT 10 capsules in the morning, middle and evening, D-5-3, 11-13, 38-40;Every 60 days/cycle, PFLL + PD-1 + FMT is given for a maximum of 6 cycles.
Control group (PFLL + PD-1) :
5-Fu 200mg/ m2 /d, D1-30 + cisplatin 80mg/ m2, d1, 28 or D1-3, 28-30 + triplizumab 240mg, d1, 22;PFLL + PD-1 is given a maximum of 6 cycles per 60 days/cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flora Transplantation group | Experimental | Drug: Intestinal bacteria freeze-dried powder capsules5-Fu+DDP+anti-PD-1 mAb+FMT |
| Control group | No intervention | –5-Fu+DDP+anti-PD-1 mAb |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-60 years old;
- Pathological diagnosis of nasopharyngeal carcinoma;
- Patients diagnosed with oligometastatic nasopharyngeal carcinoma who meet stage IVb as defined by the International Union against Cancer and the American Joint Committee on Cancer (UICC/AJCC) staging System (8th edition) (Oligometastatic as ≤3 organs and ≤5 sites of metastasis);
- Patients with metastatic nasopharyngeal carcinoma who had not previously received systematic chemotherapy for the disease in this study, except neoadjuvant chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy received 6 months before the first administration;
- Karnofsky's functional status score should be at least 70 points (if the functional status score is decreased due to tumor, it should be appropriately relaxed after the researchers' judgment, and the minimum score should be no less than 50 points, as shown in Annex I);
Key exclusion criteria (7 listed)
- allergy to 5-FU, gemcitabine, cisplatin, other monoclonal antibodies, or any component of triplimab
- Prior treatment with PD-1 receptor or its ligand PD-L1 or cytotoxic T lymphocyte-associated protein 4 (CTLA4) receptor;
- Had major surgery other than diagnosis of nasopharyngeal cancer within 28 days prior to randomization or was expected to require major surgery during the study period;
- Patients with severe damage of intestinal barrier such as sepsis, active massive bleeding of digestive tract and perforation due to various reasons;
- Currently diagnosed with fulminant colitis or toxic megacolon;
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 |
|---|---|---|
| Intestinal bacteria freeze-dried powder capsulesAlso: 5-FU+DDP+anti-PD-1 mAbOral healthy intestinal bacteria freeze-dried powder capsules, tid | Drug | Flora Transplantation group |
Primary outcome
PFS
Time frame: 1-year PFS 40%
Progression-free survival
1 secondary outcome
OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intestinal bacteria freeze-dried powder capsules in people with Nasopharyngeal Carcinoma, run by Yun-fei Xia.
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 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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. 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 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?
Results are not available in the source record.
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?
PFS (time frame: 1-year PFS 40%). 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 3 Jul 2024.