NCT07847671

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
61mo left

Started Oct 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

October 10, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 16, 2026

Last Update Submit

September 23, 2026

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Keywords

Fecal Microbiota TransplantationAdvanced Hepatocellular CarcinomaQL1706BevacizumabIparomlimabTuvonralimab

Outcome Measures

Primary Outcomes (1)

  • Objective response rate （ORR）

    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）.

    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.

Secondary Outcomes (4)

  • Disease Control Rate （DCR）

    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.

  • Progression-Free Survival （PFS)

    From first study treatment until the first documented disease progression or death from any cause, whichever occurs first, up to approximately 1 year.

  • Overall Survival （OS）

    Starting from the time of treatment until death from any cause assessed from the date of the first intervention up to 24 months.

  • Adverse events （AEs）

    30 days

Other Outcomes (2)

  • Changes in patient gut microbiome composition following FMT

    At baseline （prior to the first FMT administration）, before QL1706 plus bevacizumab administration on Days 6,27, and 48, and after the third administration （approximately 9 weeks after FMT initiation）.

  • Multi-Omics prognosis biomarker Profiles

    At baseline （prior to the first FMT administration）, before QL1706 plus bevacizumab administration on Days 6,27, and 48, and after the third administration （approximately 9 weeks after FMT initiation).

Study Arms (1)

FMT combined with QL1706 plus Bevacizumab

EXPERIMENTAL

FMT combined with QL1706 plus Bevacizumab

Drug: FMT combined with QL1706 plus Bevacizumab

Interventions

FMT combined with QL1706 plus BevacizumabDRUG

Oral Fecal Microbiota Transplantation （FMT） capsules: Full-dose FMT (80-100g) will be administered on Days 0,28, and 49. Iparomlimab and Tuvonralimab （QL1706）: QL1706 will be administered intravenously at a dose of 7.5 mg/kg, with the first administration on Day 7, followed by subsequent administrations on Days 28 and 49, thereafter every 21 days. Bevacizumab: Bevacizumab will be administered intravenously at a dose of 15 mg/kg body weight, with the first administration on Day 7, followed by subsequent administrations on Days 28 and 49, thereafter every 21 days.

FMT combined with QL1706 plus Bevacizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

Related Publications (11)

  • Qin 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

    BACKGROUND

  • Porcari 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: 41606119BACKGROUND

  • Yang 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: 38241975BACKGROUND

  • Lei 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: 40715107BACKGROUND

  • Davar 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: 33542131BACKGROUND

  • Xiao 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.

    PMID: 40314129BACKGROUND

  • Pomej K, Frick A, Scheiner B, Balcar L, Pajancic L, Klotz A, Kreuter A, Lampichler K, Regnat K, Zinober K, Trauner M, Tamandl D, Gasche C, Pinter M. Study protocol: Fecal Microbiota Transplant combined with Atezolizumab/Bevacizumab in Patients with Hepatocellular Carcinoma who failed to achieve or maintain objective response to Atezolizumab/Bevacizumab - the FAB-HCC pilot study. PLoS One. 2025 Apr 15;20(4):e0321189. doi: 10.1371/journal.pone.0321189. eCollection 2025.

    PMID: 40233040BACKGROUND

  • Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, Sukeepaisarnjaroen W, Kang YK, Van Dao T, De Toni EN, Rimassa L, Breder V, Vasilyev A, Heurgue A, Tam VC, Mody K, Thungappa SC, Ostapenko Y, Yau T, Azevedo S, Varela M, Cheng AL, Qin S, Galle PR, Ali S, Marcovitz M, Makowsky M, He P, Kurland JF, Negro A, Sangro B. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022 Aug;1(8):EVIDoa2100070. doi: 10.1056/EVIDoa2100070. Epub 2022 Jun 6.

    PMID: 38319892BACKGROUND

  • Dai S, Chen Y, Cai W, Dong S, Zhao J, Chen L, Cheng CS. Combination immunotherapy in hepatocellular carcinoma: synergies among immune checkpoints, TKIs, and chemotherapy. J Hematol Oncol. 2025 Sep 26;18(1):85. doi: 10.1186/s13045-025-01739-6.

    PMID: 41013723BACKGROUND

  • 郝运, 李川, 文天夫, 彭伟. 全球及中国的肝癌流行病学特征: 基于《2022全球癌症统计报告》解读[J]. 中国普 外基础与临床杂志, 2024, 31(7): 781-789

    BACKGROUND

  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

    PMID: 38572751BACKGROUND

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hao Jihui, PhD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

  • Zhang Ningning, PhD

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Ningning, PhD

CONTACT

+8615822153931mail4ningning@163.com

Liu Yue, PhD

CONTACT

+8615245104487liuxiaotian116@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 29, 2026

Study Start (Estimated)

October 10, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2031

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations

CN(1)