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Combined Hepatocellular and CholangiocarcinomaPhase 2NCT06855225

A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma

A Phase 2 study testing Tremelimumab, Durvalumab and Gemcitabine in people with Combined Hepatocellular and Cholangiocarcinoma, run by Mehmet Akce at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tremelimumab, Durvalumab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
Oct 2026to May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations. Informed written consent must be ≤ 28 days prior to registration.
  • Age ≥ 18 years at the time of registration.
  • Body weight > 30 kg.
  • Histological or cytological confirmation of combined hepatocellular-cholangiocarcinoma. NOTE: Locally advanced unresectable/metastatic.
  • Measurable disease according to RECIST 1.1. NOTE: See Section 9 for additional details.
  • Must have life expectancy ≥ 12 weeks.
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration.
  • Adequate organ and marrow function as defined below. All screening labs to be obtained ≤ 28 days prior to registration.
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL
  • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN). NOTE: This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician and with a Total Bilirubin < 3 x ULN.
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2. 5 x ULN unless liver metastases are present, in which case it must be ≤ 5 x ULN
  • PT and INR and aPTT ≤ 1.5 x ULN. NOTE: If patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy subject is eligible.
  • Creatinine ≤ 1.5 x ULN or Calculated creatinine clearance must be ≥ 50 mL/min using the Cockcroft-Gault formula.
  • Negative serum pregnancy test done ≤ 7 days prior to registration for women of childbearing potential only. NOTE: A female of childbearing potential is a sexually mature female who:
  • has not undergone a hysterectomy or bilateral oophorectomy; or
  • has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time preceding 12 consecutive months).
  • Archival tissue obtained within the previous 3 months is required if available. If interval systemic anti-cancer treatment was administered between the biopsy collection and C1D1 a new biopsy must be performed. Subjects that do not have archival tissue available (obtained within the previous 3 months, without interval systemic anti-cancer treatment) must be willing to undergo a biopsy prior to C1D1. All subjects will undergo an on-treatment biopsy at Week 6 (at the end of Cycle 2; ± 7 days) if deemed feasible and safe by the investigator. Peripheral blood samples are also required. All specimens will be used for correlative research purposes.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study, i.e., active treatment and safety follow-up).
  • Subject is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow-up.

Who cannot join

  • History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Participation in another clinical study with an investigational product ≤ 28 days prior to registration unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Liver directed therapy (TACE, Y-90, liver directed radiation) ≤ 28 days prior to registration. NOTE: Prior liver directed therapy > 28 days of registration is allowed as long as the subject has at least one measurable untreated lesion by RECIST v.1.1.
  • Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
  • Subjects with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the sponsor-investigator.
  • Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the sponsor-investigator.
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  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment other than the study drugs. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
  • Subjects who have received prior gemcitabine, cisplatin, anti-PD-1, anti-PD-L1 or anti-CTLA-4 for locally advanced or metastatic disease. NOTE: Prior anti-PD-1, anti-PD-L1 or anti-CTLA-4 can be allowed if it was administered for nonmetastatic and early stage disease, in that case subject:
  • Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
  • All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
  • Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Subjects with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
  • Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
  • Current or prior use of immunosuppressive medication ≤ 14 days prior to registration. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Receipt of live attenuated vaccine ≤ 30 days prior to registration. NOTE: Subjects, if enrolled, should not receive live vaccine whilst receiving study drugs and up to 30 days after the last dose of study drugs.
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation ≤ 28 days prior to registration.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Major surgical procedure (as defined by the investigator) ≤ 28 days prior to registration. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). NOTE: Subjects without active disease in the last 5 years may be included but only after consultation with the study physician. The following are exceptions to this criterion. Subjects with:
  • Vitiligo or alopecia
  • Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥ 5 years prior to registration and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression. NOTE: Subjects with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. Subjects that have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to signing the ICF are not eligible to participate. Subjects whose brain metastases have been treated may be eligible provided they show radiographic stability (defined as 2 brain scans, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤ 10mg/day of prednisone or its equivalent and anti-convulsants ≤ 14 days prior to registration. Brain metastases will not be recorded as RECIST Target Lesions at baseline.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
  • History of active primary immunodeficiency.
  • Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Subjects with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
  • Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
  • Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control as described in Section 5.5. NOTE: breast milk cannot be stored for future use while the subject is being treated on study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet Akce, MD contact

205-975-0832

makce@uabmc.edu

Ahran Lee contact

3176345842 ext. 14

alee@hoosiercancer.org

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Mehmet Akce, MD, makce@uabmc.edu

    Margaret Thomas, 2058951802, margaretannthomas@uabmc.edu

Other trials in United States

About this study

Official title: A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab (STRIDE) Plus Gemcitabine and Cisplatin (GEMCIS) in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma (cHCC-CCA)

This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Cycles 1 through 8 will be in 3 week intervals and Cycles 9+ will be in 4 week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur at screening and then every 9 weeks until the end of Cycle 9. Disease assessments will then occur every 8 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months treatment from Cycle 1 Day 1 is allowed.

Being tested
Tremelimumab, Durvalumab, Gemcitabine, Cisplatin
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TremelimumabDrug

    Also called Imjudo

    Tremelimumab is administered at 300mg intravenously once at Cycle 1.

  • DurvalumabDrug

    Also called Imfinzi

    Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only.

  • CisplatinDrug

    Also called Platinol

    Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only.

Study groups in NCT06855225
Study groupRoleWhat they receive
Single Tremelimumab with Regular Interval Durvalumab plus Gemcitabine and CisplatinExperimentalCycles 1 through 8 will be in 3-week intervals and Cycles 9+ will be in 4-week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only.
Receives: Drug: Tremelimumab; Drug: Durvalumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed objective response rate (ORR)

    ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST version 1.1. A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

    Measured: 24 months

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS is defined as the time from registration to death from any cause.

    Measured: 24 months

  2. Progression-free survival (PFS)

    PFS is defined as the time from registration to disease progression, as defined by RECIST 1.1, or until death, whichever occurs first.

    Measured: 24 months

  3. Disease control rate (DCR)

    Disease control is defined as achieving complete response (CR), partial response (PR), or maintaining stable disease (SD) for at least 4 months (at time of second scan) while on treatment. Objective status will be assessed using RECISTv1.1 criteria. The Evaluable Population will be used. Disease control rate will be calculated as the proportion of evaluable subjects who achieve disease control.

    Measured: 24 months

  4. Adverse Event Rates

    The Safety Population will be used for adverse event analyses according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5. The rate of subjects experiencing at least one Grade 3+ adverse event (regardless of attribution) will be reported.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study startOct 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855225
Sponsor's protocol ID
HCRN GI24-671
Status last verified
Oct 2026
First submitted
25 Feb 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tremelimumab, Durvalumab and Gemcitabine in people with Combined Hepatocellular and Cholangiocarcinoma, run by Mehmet Akce at 1 site in United States.

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 21 inclusion and 40 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Akce, MD (205-975-0832, makce@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed objective response rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06855225.

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 5 Oct 2026.

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