AzTrials
AzTrials

Intrahepatic CholangiocarcinomaPhase 2NCT05781958

Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC

A Phase 2 study testing Cadonilimab+Gem/Cis in people with Intrahepatic Cholangiocarcinoma, run by Shen Feng at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

TOPAZ-1 phase III trail demonstrated that the addition of immune checkpoint inhibitor anti-PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. 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?
Cadonilimab+Gem/Cis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
24 Nov 2022to 1 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically or cytologically diagnosed intrahepatic cholangiocarcinoma (ICC)
  • At least 1 measurable lesion (according to RECIST1.1)
  • Have not previously received any systemic treatment
  • Age 18-75 years old, both male and female
  • ECOG performance status score (PS score) 0-2 point
  • Adequate medullary hematopoiesis function: Neutrophils≥1.5*10^9/L; platelets≥100*10^9/L
Show all 11Show fewer
  • Adequate renal function: creatinine clearance > 60ml/min
  • Adequate hepatic function: Bilirubin ≤ 1.5 times the upper limit of normal
  • No cardiac insufficiency or chest pain (medically uncontrollable); no myocardial infarction in the 12 months prior to study initiation
  • Expectation survival time over 3 months
  • The patient must sign an informed consent form

Who cannot join

  • History of another primary malignancy
  • Brain metastases or spinal cord compression
  • Uncontrolled intercurrent illness
  • Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc)
  • Have received allogeneic organ transplantation
  • Control of concurrent complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, poorly controlled arrhythmia, active interstitial lung disease ( ILD), severe chronic gastrointestinal disorders associated with diarrhea symptoms, may limit compliance with the psychiatric/social conditions required by the trial, and substantially increase the risk of adverse events or affect the ability of patients to sign written consent forms
Show all 12Show fewer
  • History of active primary immunodeficiency
  • Pregnant or lactating women
  • Severe or uncontrolled infections
  • Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy;
  • Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;
  • Patients are unsuitable for the enrollment according to investigator's judgement.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Eastern hepatobilliary surgery hospital

    Shanghai, Shanghai Municipality, 20043

Other trials in China

About this study

Official title: Cadonilimab Combined With Gemcitabine and Cisplatin as First Line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma: A Single Center, Single Arm, Phase II Trial

TOPAZ-1 phase III trail demonstrated that the addition of immune checkpoint inhibitor anti-PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with gemcitabine and cisplatin as first Line therapy in patients with advanced intrahepatic cholangiocarcinoma. Eligible participants will receive cadonilimab (up to 12 months) plus gemcitabine and cisplatin (for maximum of 6-8 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.

Being tested
Cadonilimab+Gem/Cis
Keywords
cadonilimab (anti-PD-1/CTLA-4 bispecific antibody)
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • Cadonilimab+Gem/CisDrug

    Cadonilimab (500mg, iv, Q3W, Day1) with gemcitabine(1000mg/m^2, iv, Q3W, Day1and Day8) plus cisplatin(25mg/m^2, iv, Q3W, Day1and Day8) up to 8 cycles followed by cadonilimab (500mg, iv, Q3W, Day1) plus capecitabine（1000 mg/m^2 orally according to Body Surface Area (BSA)，BID，Q3W，on Days 1-14）as maintenance therapy until disease progression or other discontinuation criteria, up to 24months.

Study groups in NCT05781958
Study groupRoleWhat they receive
Cadonilimab+Gem/CisExperimentalNot described
Receives: Drug: Cadonilimab+Gem/Cis

What is being measured

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

  1. Objective response rate (ORR) per RECIST 1.1

    Defined as patients achieving a complete response [CR] or partial response [PR]

    Measured: Up to two years

Secondary outcomes (5)

  1. Progression free survival (PFS) per RECIST 1.1

    Defined as the time from the start of treatment to the date of progressive disease, or death, whichever occurred first.

    Measured: Up to two years

  2. Desease control rate (DCR) per RECIST 1.1

    CR + PR + SD

    Measured: Up to two years

  3. Overall survival (OS)

    Defined as the time from the start of treatment to the date of death from any cause

    Measured: Up to two years

  4. 6mo PFS rate per RECIST 1.1

    Progression-free survival (PFS) rate at 6 months

    Measured: at 6 months

  5. adverse events

    Include Treatment emerge adverse events, treatment related adverse events and serious adverse events

    Measured: Up to two years

Timeline

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

  1. First posted23 Mar 2023
  2. Study start24 Nov 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2024 (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
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05781958
Sponsor's protocol ID
EHBHKY2022-H039-P001
Status last verified
Oct 2023
First submitted
20 Feb 2023
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab+Gem/Cis in people with Intrahepatic Cholangiocarcinoma, run by Shen Feng 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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) per RECIST 1.1 (time frame: Up to two 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 NCT05781958.

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 2 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in