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Intrahepatic Cholangiocarcinoma (Icc)Phase 2GOLD-HAICNCT06852287

Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

A Phase 2 study testing chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab. in people with Intrahepatic Cholangiocarcinoma (Icc) and Gall Bladder Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
1 Sep 2024to 1 Sep 2026
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

  • Age 18 or above
  • Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
  • A tumor that cannot be removed by three independent surgeons.
  • Expected lifespan ≥ 12 weeks
  • ECOG PS score 0-1 points
  • The patient voluntarily participates and signs an informed consent form;
  • Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.

Who cannot join

  • Use any systemic research anti-cancer drugs
  • Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
  • Asthma requires the use of bronchodilators for medical intervention
  • Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
  • Clinical symptoms or uncontrolled heart disease
  • Severe infection within 4 weeks before the first use of medication
Show all 9Show fewer
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Vaccination with attenuated live vaccine within 4 weeks before treatment
  • Other systemic malignant tumors in the past 5 years

Trial locations and contacts

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

Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer contact

86-2223340123 ext. 3090

zhang.wei@tmu.edu.cn

wei zhang, surgical chief physician, M.D., Ph.D. contact

8618622025401

zhang.wei@tmu.edu.cn

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tia, 300060

    Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer, 8618622025401, zhang.wei@tmu.edu.cn

    Recruiting

Other trials in China

About this study

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.

This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.

Being tested
chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Keywords
GemOX, Lenvatinib, Toripalimab
Medical subject headings
Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Gallbladder Neoplasms

What participants receive

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

  • chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.Drug

    Toripalimab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd) Chemotherapy by hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.

Study groups in NCT06852287
Study groupRoleWhat they receive
GemOX hepatic arterial infusion combined with lenvatinib and ToripalimabExperimentalTriprolizumab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd); Chemotherapy hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.
Receives: Drug: chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is a key metric commonly used to assess the efficacy of cancer treatments, especially in clinical trials. It primarily measures the proportion of patients who exhibit a significant reduction in tumor size following treatment. Here's a detailed explanation of ORR:

    1. Definition: ORR refers to the percentage of patients who experience a notable reduction in tumor size within a specified timeframe after receiving treatment. It typically encompasses two types of responses: Complete Response (CR): The tumor completely disappears, confirmed by follow-up assessments showing no measurable tumor. Partial Response (PR): The tumor size is reduced by a certain percentage (usually 30% or more), but measurable tumor remains.
    2. Calculation Method

    The formula for calculating ORR is as follows:

    ORR=CR+PR.

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. Surgical resection rate

    Surgical resection rate is the proportion of patients who underwent surgical resection among all patients

    Measured: through study completion, an average of 1 year

  2. Pathological complete response rate (pCR rate)

    Pathological complete response rate (pCR rate) is the proportion of patients who underwent surgical resection who achieved pathological complete response.

    Measured: through study completion, an average of 1 year

  3. Overall survival (OS)

    Overall survival time (OS) is the time from enrollment in clinical trials to patient death or loss to follow-up.

    Measured: through study completion, an average of 5 years

Timeline

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

  1. First posted28 Feb 2025
  2. Study start1 Sep 2024
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2026 (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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852287
Sponsor's protocol ID
E20241047
Other IDs
GOLD-HAIC
Acronym
GOLD-HAIC
Status last verified
Feb 2025
First submitted
20 Oct 2024
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.

    PubMed 40812353

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab. in people with Intrahepatic Cholangiocarcinoma (Icc) and Gall Bladder Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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 China. 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 Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer (86-2223340123 ext. 3090, zhang.wei@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: through study completion, an average of 1 year). 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 NCT06852287, which also lists 1 linked publication.

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 28 Feb 2025.

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