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Intrahepatic CholangiocarcinomaPhase 2GOTNCT05557578

GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence

A Phase 2 study testing Tislelizumab combined with GEMOX (GOT) regimen in people with Intrahepatic Cholangiocarcinoma, run by Zhejiang Cancer Hospital at 2 sites 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

Intrahepatic cholangiocarcinoma (ICC) arises from the epithelial cells of bile ducts and occurs proximal to the segmental biliary ducts. ICC is highly aggressive, long-term survival only can be achieved in patients with R0 surgical resection. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
Tislelizumab combined with GEMOX (GOT) regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
5 May 2023to Dec 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 yo;
  • Patients of Pathological confirmed intrahepatic cholangiocarcinoma who has never received systemic therapy including chemotherapy, immunotherapy, target therapy and other anti-cancer therapy;
  • Patients of resectable ICC with high risk recurrent factors:
  • ①Maximum diameter greater than 5cm or multiple tumors.
  • ②Preoperative CA19-9 greater than 200 Unit(U)/mL
  • ③Tumors invaded adjacent blood vessels
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  • ④Preoperative radiology hints suspected regional lymph node metastasis.
  • ⑤Tumor tissues confirmed by CT or MRI, at least one measurable lesion exists according to RECIST v1.1.
  • Eastern Cooperative Oncology Group(ECOG)-Performance status(PS) score is 0 before first drug administration;
  • Child-Pugh classification is class A;
  • Estimated overall survival is greater than 16 weeks;
  • The level of organ function meets the criteria and can tolerate surgery before the first treatment. Main organs meet the criteria as below:
  • haemoglobin≥90g/L，Neutrophil count≥1.5×10⁹/L，Platelet count≥100×10⁹/L；Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN），alkaline phosphatase≤2.5 ULN，Serum albumin≥30g/L；serum creatinine<1.5 ULN；International normalized ratios（INR）≤2 or Prothrombin time（PT）exceed ULN≤6s；Creatinine clearance≥60 mL/min.
  • Male and female subjects with potential fertility had to agree to the use of effective contraceptive methods throughout the study period；
  • Sign an informed consent form agreeing to provide previously preserved specimens of tumor tissue or fresh detection of tumor lesions.

Who cannot join

  • Patient with non-intrahepatic cholangiocarcinoma；
  • Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study (except for previous non-tumor-related surgeries and diagnostic biopsies)；
  • Distant metastasis；
  • hepatitis B virus (HBV) DNA>2000 copies/ml, hepatitis C virus (HCV) RNA>1000;
  • Long-term glucocorticoid users require long-term systemic hormones (equivalent to >10 mg Prednisone/day) or any other form of immunosuppressive therapy；
  • Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy；
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  • Patients with complete bowel obstruction and incomplete intestinal obstruction that require treatment, but patients who have been relieved of obstruction by ostomy or stent placement can be enrolled；
  • Active severe clinical infections (> grade 2, NCI-CTCAE version 5.0), including active TB; Have a history of active TB infection at least 1 year before enrolment, have not received regular anti-tuberculosis (TB) treatment or are still active; active, known or suspected autoimmune disease;
  • Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L), severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease). except for recovered radiation pneumonia);
  • Clinically significant cardiovascular diseases; With hypertension, antihypertensive drugs cannot be well controlled (systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
  • Patient who are receiving renal replacement therapy；
  • History of other malignancies in the last 5 years. With the exception of carcinoma of the skin basal cells that have been cured or carcinoma in situ in the cervix;
  • Others situations are not expected to tolerate surgical treatment；
  • People with allergic reactions to any component of the drug under study;
  • There are other unsuitable candidates for clinical trials, such as alcohol dependence, mental illness, pregnancy (or lactation).

Trial locations and contacts

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

Chaoqun Fei contact

+086-0571-88122564

ec@zjcc.org.cn

China2 sites, 2 recruiting

  • 1# Banshan East Rd. Zhejiang cancer hospital

    Hangzhou, Zhejiang, 310022

    Yuhua - Zhang, M.D., +86-0571-88128058, drzhangyuhua@126.com

    Jia - Wu, +86-0571-88128052, tkds123@qq.com

    Not yet recruiting

  • Jia Wu

    Hanzhou, Zhejiang, 310000

    Jia Wu, 086-0571-88128058, tkds123@qq.com

    Recruiting

Other trials in China

About this study

Official title: Tislelizumab Combined with GEMOX (GOT) Applied As Neoadjuvant Regimen for Patients of Resectable Intrahepatic Cholangiocarcinoma with High-risk Factors of Recurrence: a Single Arm, Single Center, Prospective, Explorative Clinical Trail.

Intrahepatic cholangiocarcinoma (ICC) arises from the epithelial cells of bile ducts and occurs proximal to the segmental biliary ducts. ICC is highly aggressive, long-term survival only can be achieved in patients with R0 surgical resection. Large diameter of tumor, multiple tumors, preoperative carbohydrate antigen(CA)19-9 elevated, tumors invaded adjacent blood vessels and preoperative radiology hints suspected regional lymph node metastasis were considered as high-risk factors of recurrence in the previous study. Chemotherapy can trigger antigen release and induces strong anti-tumor effects of T cells due to cytotoxic cell death. Immune checkpoint inhibitors can relieve tumor immunosuppressive microenvironment. Hence, we aim to investigate objective response rate and R0 resection rate and survival rate of patients with high-risk factors of recurrence who receives Tislelizumab combined with GEMOX regimen(GOT) as a neoadjuvant therapy.

Being tested
Tislelizumab combined with GEMOX (GOT) regimen
Keywords
Tislelizumab, Gemcitabine, Oxaliplatin, cholangiocarcinoma, Neoadjuvant
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • Tislelizumab combined with GEMOX (GOT) regimenDrug

    Also called Gemcitabine, Oxaliplatin

    Tislelizumab 200mg on day 1；Gemcitabine 1000mg/m2 on day 1、8；Oxaliplatin 135mg/m2 on day 1；cycle 3 weeks

Study groups in NCT05557578
Study groupRoleWhat they receive
Experimental armExperimentalTislelizumab combined with GEMOX (GOT) regimen
Receives: Drug: Tislelizumab combined with GEMOX (GOT) regimen

What is being measured

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

  1. Objective response rate (ORR)

    The proportion of patients who achieved complete response (CR) and partial response(PR) after GOT regimen neoadjuvant treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

    Measured: Up to 6 cycle treatment (each cycle is 21 days), an average of 18 weeks.

  2. R0 resection rate

    The proportion of patients who achieved pathological negative surgical margin after GOT regimen neoadjuvant treatment.

    Measured: Up to pathological report come out, an average of 20 weeks.

Secondary outcomes (3)

  1. Disease control rate (DCR)

    The proportion of patients who achieved complete response (CR), partial response (PR) and stable disease (SD) after GOT regimen neoadjuvant treatment according to RECIST v1.1.

    Measured: Up to 6 cycle treatment (each cycle is 21 days), an average of 18 weeks.

  2. Recurrence free survival

    The time between the date of patients underwent radical resection and the date of radiographic recurrence as defined by RECIST1.1.

    Measured: From date when patients are received radical resection until the date of first documented recurrence radiologically, assessed at least 12 months.

  3. Overall survival

    The time between the date of patients underwent radical resection and death from any cause.

    Measured: From date when patients are received radical resection until the date of death from any cause, assessed at least 12 months.

Timeline

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

  1. First posted28 Sep 2022
  2. Study start5 May 2023
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completionDec 2025 (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
Model description
Patients of Resectable ICC With High-risk Factors of Recurrence
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557578
Sponsor's protocol ID
ZhangYH
Acronym
GOT
Status last verified
Dec 2024
First submitted
19 Sep 2022
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab combined with GEMOX (GOT) regimen in people with Intrahepatic Cholangiocarcinoma, run by Zhejiang Cancer Hospital at 2 sites 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 15 inclusion and 15 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 11 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 2 sites 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 Chaoqun Fei (+086-0571-88122564, ec@zjcc.org.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: Up to 6 cycle treatment (each cycle is 21 days), an average of 18 weeks.). The study lists 2 primary outcomes in all. 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 NCT05557578.

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 11 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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