PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPC,a Phase III ,Open, Randomized Clinical Trial.

Last updated: June 26, 2024
Sponsor: Yun-fei Xia
Overall Status: Active - Not Recruiting

Phase

3

Condition

Nasopharyngeal Cancer

Treatment

Intestinal bacteria freeze-dried powder capsules

Clinical Study ID

NCT06486220
2023-FXY-120
  • Ages 18-60
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18-60 years old;

  2. Pathological diagnosis of nasopharyngeal carcinoma;

  3. Patients diagnosed with oligometastatic nasopharyngeal carcinoma who meet stage IVbas defined by the International Union against Cancer and the American JointCommittee on Cancer (UICC/AJCC) staging System (8th edition) (Oligometastatic as ≤3organs and ≤5 sites of metastasis);

  4. Patients with metastatic nasopharyngeal carcinoma who had not previously receivedsystematic chemotherapy for the disease in this study, except neoadjuvantchemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy received 6months before the first administration;

  5. Karnofsky's functional status score should be at least 70 points (if the functionalstatus score is decreased due to tumor, it should be appropriately relaxed after theresearchers' judgment, and the minimum score should be no less than 50 points, asshown in Annex I);

  6. According to the RECIST1.1 evaluation criteria, there should be at least 1measurable lesion, and the measurable lesion should not have received localtreatment such as radiotherapy;

  7. Expected survival ≥3 months;

  8. A tolenrant organs.

Exclusion

Exclusion Criteria:

  1. allergy to 5-FU, gemcitabine, cisplatin, other monoclonal antibodies, or anycomponent of triplimab

  2. Prior treatment with PD-1 receptor or its ligand PD-L1 or cytotoxic Tlymphocyte-associated protein 4 (CTLA4) receptor;

  3. Had major surgery other than diagnosis of nasopharyngeal cancer within 28 days priorto randomization or was expected to require major surgery during the study period;

  4. Patients with severe damage of intestinal barrier such as sepsis, active massivebleeding of digestive tract and perforation due to various reasons;

  5. Currently diagnosed with fulminant colitis or toxic megacolon;

  6. Enteral nutrition patients who cannot tolerate 50% of heat calorie requirements dueto severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinalbleeding, high-flow intestinal fistula, etc.;

  7. patients with any active autoimmune disease or a history of autoimmune diseases.

Study Design

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: Intestinal bacteria freeze-dried powder capsules
Phase: 3
Study Start date:
July 01, 2024
Estimated Completion Date:
July 01, 2026

Study 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.