Clinical trial · Interventional
Fecal Microbiota Transplantation With QL1706 Plus Bevacizumab for Advanced HCC
Fecal Microbiota Transplantation （FMT） Combined With QL1706 Plus Bevacizumab as First-line Treatment for Advanced HCC
NCT07847671CI-TRIAL-00126701not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
This is a prospective, single-center, single-arm Phase II pilot study designed to evaluate the efficacy and safety of FMT in combination with QL1706 and Bevacizumab as first-line treatment for advanced Hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FMT combined with QL1706 plus Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FMT combined with QL1706 plus Bevacizumab
- description
- FMT combined with QL1706 plus Bevacizumab
- interventionNames
- Drug: FMT combined with QL1706 plus Bevacizumab
Primary outcomes (1)
- measure
- Objective response rate （ORR）
- timeFrame
- Every 9 weeks from the first dose of FMT administration until the first documented disease progression, death or study completion, up to approximately 1 year.
- description
- To assess the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to Objective Response Rate （ORR）.
Secondary outcomes (4)
- measure
- Disease Control Rate （DCR）
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years. * Confirmed imaging or histological diagnosis of unresectable HCC. * Treatment-naïve unresectable or metastatic HCC. * BCLC Stage C. * Child-Pugh A. * ECOG PS 0-1. Main Exclusion Criteria: * Prior treatment with an immune checkpoint inhibitor, or prior systemic therapy for advanced HCC. * Histologic subtypes other than hepatocellular carcinoma, including fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular cholangiocarcinoma. * Active or prior autoimmune disease, immunodeficiency requiring systemic immunosuppressive therapy. * Clinically significant bleeding risk, coagulopathy, or untreated high-risk esophagogastric varices. * Any contraindication to fecal microbiota transplantation. * Uncontrolled intercurrent illness, including active infection, clinically significant cardiovascular disease, central nervous system metastases. * Pregnancy or breastfeeding.
References
Publications (11)
- BACKGROUNDQin S, Fan J, Yang F ... LBA38 Iparomlimab and tuvonralimab (QL1706) with bevacizumab and/or chemotherapy in first-line (1L) treatment of advanced hepatocellular carcinoma (aHCC): A randomized, open-label, phase II/III study (DUBHE-H-308) Annals of Oncology, 35, S1229-S1230
- BACKGROUNDPorcari S, Ciccarese C, Heidrich V, Rondinella D, Quaranta G, Severino A, Arduini D, Buti S, Fornarini G, Primi F, Stumbo L, Giannarelli D, Giudice GC, Damassi A, Giron Berrios JR, Puncochar M, Barbazuk TB, Piccinno G, Pinto F, Armanini F, Asnicar F, Schinzari G, Derosa L, Kroemer G, Sanguinetti M, Masucci L, Gasbarrini A, Tortora G, Cammarota G, Zitvogel L, Segata N, Iacovelli R, Ianiro G. Fecal microbiota transplantation plus pembrolizumab and axitinib in metastatic renal cell carcinoma: the randomized phase 2 TACITO trial. Nat Med. 2026 Apr;32(4):1316-1324. doi: 10.1038/s41591-025-04189-2. Epub 2026 Jan 28. PMID 41606119
- BACKGROUNDYang Y, An Y, Dong Y, Chu Q, Wei J, Wang B, Cao H. Fecal microbiota transplantation: no longer cinderella in tumour immunotherapy. EBioMedicine. 2024 Feb;100:104967. doi: 10.1016/j.ebiom.2024.104967. Epub 2024 Jan 18. PMID 38241975
- BACKGROUNDLei W, Zhou K, Lei Y, Li Q, Zhu H. Gut microbiota shapes cancer immunotherapy responses. NPJ Biofilms Microbiomes. 2025 Jul 25;11(1):143. doi: 10.1038/s41522-025-00786-8. PMID 40715107
- BACKGROUNDDavar D, Dzutsev AK, McCulloch JA, Rodrigues RR, Chauvin JM, Morrison RM, Deblasio RN, Menna C, Ding Q, Pagliano O, Zidi B, Zhang S, Badger JH, Vetizou M, Cole AM, Fernandes MR, Prescott S, Costa RGF, Balaji AK, Morgun A, Vujkovic-Cvijin I, Wang H, Borhani AA, Schwartz MB, Dubner HM, Ernst SJ, Rose A, Najjar YG, Belkaid Y, Kirkwood JM, Trinchieri G, Zarour HM. Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients. Science. 2021 Feb 5;371(6529):595-602. doi: 10.1126/science.abf3363. PMID 33542131
- BACKGROUNDXiao K, Li K, Xiao K, Yang J, Zhou L. Gut Microbiota and Hepatocellular Carcinoma: Metabolic Products and Immunotherapy Modulation. Cancer Med. 2025 May;14(9):e70914. doi: 10.1002/cam4.70914.