Advanced Hepatocellular Carcinoma (HCC)Phase 2NCT07847671
Fecal Microbiota Transplantation Combined With QL1706 Plus Bevacizumab for Advanced HCC
A Phase 2 study testing FMT combined with QL1706 plus Bevacizumab in people with Advanced Hepatocellular Carcinoma (HCC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- FMT combined with QL1706 plus Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to Oct 2031
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Liu Yue, PhD, +8615245104487, liuxiaotian116@163.com
Hao Jihui, MD, PhD
About this study
Official title: Fecal Microbiota Transplantation （FMT） Combined With QL1706 Plus Bevacizumab as First-line Treatment for Advanced HCC
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.
Read the detailed description
Iparomlimab and Tuvonralimab （QL1706）, constitute a bifunctional antibody target both programmed death-1 and cytotoxic T lymphocyte-associated protein-4.
The purpose of this pilot study is to assess the efficacy and safety of fecal microbiota transplantation （FMT） combined with QL1706 Plus Bevacizumab as first-line treatment for advanced HCC.
The primary objective is to test the efficacy of FMT combined with QL1706 Plus Bevacizumab, as measured by objective response rate （ORR）.
The secondary objectives are to assess and test the safety of FMT in combination with QL1706 Plus Bevacizumab as first-line treatment for advanced HCC as measured by Disease Control Rate （DCR）, Duration of Response（DoR), Progression-Free Survival （PFS）, Overall Survival （OS), and Adverse Events （AEs).
Furthermore, this study aims to investigate multi-omics prognosis prediction biomarkers and their associated mechanisms.
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- FMT combined with QL1706 plus Bevacizumab
- Keywords
- Fecal Microbiota Transplantation, Advanced Hepatocellular Carcinoma, QL1706, Bevacizumab, Iparomlimab, Tuvonralimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| FMT combined with QL1706 plus Bevacizumab | Experimental | FMT combined with QL1706 plus Bevacizumab Receives: Drug: FMT combined with QL1706 plus Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）.
Measured: 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）
To observe and evaluate the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for unresectable or metastatic HCC with respect to Disease Control Rate （DCR) determined by the radiologist per mRECIST v1.1 criteria.
Measured: 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)
Time from the start of treatment to the first documented disease progression as determined by the radiologist per mRECIST/ RECIST v1.1 criteria or death from any cause.
Measured: 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）
To observe and evaluate the efficacy of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to overall survival （OS).
Measured: 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）
To observe and evaluate the safety of FMT combined with QL1706 plus Bevacizumab as first-line treatment for metastatic HCC with respect to adverse events （AEs） AEs will be graded according to NCI-CTCAE V5.0 Safety assessments will be performed from baseline through 30 days （±7 days） after the last dose of study treatment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Jihui, MD, PhD, Principal investigator, Tianjin Medical University Cancer Institute and HospitalZhang Ningning, MD, PhD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847671
- Sponsor's protocol ID
- IRB20260196
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 41606119Yang 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.
PubMed 38241975Lei 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.
PubMed 40715107Davar 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.
PubMed 33542131Xiao 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.
PubMed 40314129Pomej 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.
PubMed 40233040Abou-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.
PubMed 38319892Dai 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.
PubMed 41013723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
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.
PubMed 38572751