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AzTrials

Intrahepatic Cholangiocarcinoma (Icc)Phase 2SED-RO-ICCNCT06946849

Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced/Oligometastatic ICC After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study

A Phase 2 study testing radiotherapy and FOLFIRI or FOLFOX or Regorafenib in people with Intrahepatic Cholangiocarcinoma (Icc), run by Shanghai Zhongshan Hospital at 1 site in China.

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

Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma (Icc)
What is being tested?
radiotherapy and FOLFIRI or FOLFOX or Regorafenib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteChina
Study dates
1 Jun 2025to 31 May 2027
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Advanced or metastatic intrahepatic cholangiocarcinoma confirmed by histopathology that cannot be surgically removed.
  • Failed to receive first-line standard treatment. (3) Definition of oligometastatic/locally advanced unresectable BTC disease: not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery.
  • Definition of oligometastatic disease: patients with distant organ metastasis or nonregional lymph node metastasis, or distant organ/nonregional lymph node metastasis and regional lymph node metastasis, as defined by the American Joint Committee on Cancer, 8th edition. The total number of metastases is ≤5 and the number of metastases in any single organ system (e.g., lung, liver) is ≤3.
  • All sites of disease must be amenable to radiotherapy and can be safely treated. Each lesion is counted separately at the time of registration and contributes to the total number of metastases. For regional lymph nodes metastases, all positive regional lymph nodes are counted together as one lesion. For nonregional lymph node metastases, adjacent metastatic lymph nodes can be treated as one lesion. Lesions that have subsided during previous treatment (i.e., are no longer visible on CT scan or have eliminated affinity on positron emission tomography [PET]-CT) are not included in the total number. At least one metastatic lesion meets the RECIST v1.1 criteria for assessable lesions. Bone metastases without soft tissue involvement can be included but are not considered assessable lesions. However, if bone metastases have soft tissue involvement and meet the criteria for assessable lesions, they are considered measurable lesions.
  • Patients who experience recurrence after curative surgery with a time interval of >6 months can be eligible for inclusion. If adjuvant therapy (excluding radiotherapy) is administered, the patient must have completed adjuvant therapy for a period of at least 6 months before meeting the inclusion criteria.
  • Primary tumor lesions and all metastases of current diagnosis have not received local treatment, such as radiotherapy, surgery or radiofrequency ablation, prior to enrollment.
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  • The patient is over 18 years old and has an Eastern Cooperative Oncology Group score of 0-1; (7) Life expectancy is greater than 12 weeks. (8) Vital organ function meets the following requirements: absolute neutrophil count ≥1.5 × 109/l; platelet count ≥100 × 109/l; hemoglobin ≥9 g/dl; serum albumin ≥2.8 g/dl; total bilirubin ≤1.5 × upper limit of normal (ULN) and alanine transaminase, aspartate aminotransferase and/or alkaline phosphatase ≤2.5 × ULN (if there is liver metastasis, alanine transaminase and/or aspartate aminotransferase ≤5 × ULN; if there is liver metastasis or bone metastasis, alkaline phosphatase ≤5 × ULN); serum creatinine ≤1.5 × ULN or creatinine clearance >60 ml/min. For patients with pulmonary lesions or previous lung irradiation who are known or suspected to have impaired lung function, the forced expiratory volume for 1 second of lung function must be above 1 l.
  • Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 h prior to randomization. Subjects must agree to adequate contraception during the trial.
  • Each patient is voluntarily enrolled, and the informed consent form is signed by the patient or their legal representative.

Who cannot join

  • (1) Histology includes components of mixed hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or biliary adenocarcinoma.
  • Complete response to four cycles of first-line systemic treatment (i.e. no measurable target for radiotherapy).
  • There is new metastasis during the four cycles of first-line systemic treatment and the number of metastases is more than five.
  • Patient has uncontrolled brain metastases or vertebral body metastasis with spinal cord compression symptoms.
  • The toxicity of previous antitumor treatment has not recovered to ≤1 based on National Cancer Institute Common Terminology Criteria for Adverse Events v4.03 (except for hair loss) or the level specified by the inclusion/exclusion criteria.
  • Patient has uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage.
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  • Patient is a pregnant or breastfeeding woman. (8) Patient has a history of immunodeficiency or severe medical disease that is not well controlled and may have an effect on study treatment.
  • Any other malignant tumor has been diagnosed within 5 years prior to or after the diagnosis of BTC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate >90%), such as well-treated basal cell or squamous cell skin cancer or cervical cancer in situ.
  • Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

Trial locations and contacts

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

Qianqian Zhao contact

+8618217008910

zhao.qianqian1@zs-hospital.sh.cn

China1 site

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Qianqian Zhao, drzhaoqq@163.com

Other trials in China

About this study

Official title: Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced/Oligometastatic Intrahepatic Cholangiocarcinoma After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study

Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study.

Read the detailed description

Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study. Eligible patients will be randomized in a 1:1 ratio to receive either second-line regimen alone (control arm) or second-line regimen plus consolidative radiotherapy to all sites of known disease (investigational arm). patients in both arms have the option of receiving upfront or subsequent standard palliative radiotherapy to any symptomatic sites requiring prompt intervention. Because of the different treatment modalities in the study, it is not possible to blind the patient or physician to the treatment arm. Follow-up for tumor assessment will conclude 52 weeks after randomization.

Being tested
radiotherapy, FOLFIRI or FOLFOX or Regorafenib
Keywords
Intrahepatic Cholangiocarcinoma, Radiotherapy, Second-line regimen
Medical subject headings
Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension

What participants receive

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

  • radiotherapyRadiation

    Radiotherapy

  • FOLFIRI or FOLFOX or RegorafenibDrug

    FOLFIRI or FOLFOX or Regorafenib

Study groups in NCT06946849
Study groupRoleWhat they receive
2L SoC+RTExperimental2L SoC regimen combined with radiotherapy
Receives: Radiation: radiotherapy; Drug: FOLFIRI or FOLFOX or Regorafenib
2L-SoCActive comparatorNot described
Receives: Drug: FOLFIRI or FOLFOX or Regorafenib

What is being measured

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

  1. PFS

    PFS is will be measured from the randomization to progression or death from any cause. Progression includes enlargement of target lesions and development of new distant metastases and will be assessed using RECIST 1.1.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. OS

    OS will be the time from randomization until death from any cause.

    Measured: Up to 2 years

  2. LCR

    Local control of all metastases (refers to all lesions present at time of randomization) will be measured from date of randomization until progression of target lesions.

    Measured: Up to 2 years

  3. AEs

    Toxicity will involve treatment-related toxicity, including early and late toxicity, as assessed using Common Terminology Criteria for Adverse Events v5.0. All adverse events occurring from randomization until 3 months after the end of treatment, regardless of relatedness to study medication, will be recorded as acute toxicities. Adverse events considered relevant and occurring later than 3 months after the end of treatment will be recorded as late toxicities.

    Measured: Up to 2 years

Timeline

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

  1. First posted27 Apr 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06946849
Sponsor's protocol ID
KY2025087
Other IDs
KY2025XXX
Acronym
SED-RO-ICC
Status last verified
Apr 2025
First submitted
19 Apr 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiotherapy and FOLFIRI or FOLFOX or Regorafenib in people with Intrahepatic Cholangiocarcinoma (Icc), run by Shanghai Zhongshan 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 9 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: opening soon, as of the sponsor's last update on 27 Apr 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 Qianqian Zhao (+8618217008910, zhao.qianqian1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Up to 2 years). 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 NCT06946849.

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 27 Apr 2025.

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