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.
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
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc), Gall Bladder Cancer
- 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
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
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- 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
China1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| GemOX hepatic arterial infusion combined with lenvatinib and Toripalimab | Experimental | Triprolizumab: 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.
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:
- 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.
- 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)
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
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
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.
- First posted28 Feb 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic Cholangiocarcinoma (Icc)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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Tianjin Medical University Cancer Institute and Hospital
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