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Intrahepatic CholangiocarcinomaPhase 2NCT04454905

Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study

A Phase 2 study testing Camrelizumab and Apatinib in people with Intrahepatic Cholangiocarcinoma, run by Sun Yat-sen University at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with advanced intrahepatic cholangiocarcinoma (ICC). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
Camrelizumab and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesChina
Study dates
1 Aug 2020to 1 Jul 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed advanced ICC, or combined hepatocellular and cholangiocarcinoma (cHCC-CC, composition of cholangiocarcinoma >50%). nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.
  • Have at least one measurable lesion (in accordance with RECIST v1.1); the measurable lesion has a long diameter ≥ 10 mm or lymphadenopathy has a short diameter ≥ 15 mm in spiral CT scan.
  • Child-Pugh Class: Grade A
  • ECOG-PS score 0 or 1
  • Life Expectancy of at least 3 months
  • Have the required screening laboratory values

Who cannot join

  • Extrahepatic cholangiocarcinoma (EHCC) and primary liver cancer. other active malignant tumors except for ICC within 3 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled.
  • Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled with hormone replacement therapy only can be enrolled]); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled;
  • Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form.
  • Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1), or previous use of Apatinib.
  • Known history of serious allergy to any monoclonal antibody or Apatinib.
  • Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption.
Show all 9Show fewer
  • Previous or current presence of metastasis to central nervous system.
  • Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study);
  • Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.

Trial locations and contacts

2 sites in 1 country.

Li Xu, MD., PhD. contact

+862087343582

xuli@sysucc.org.cn

Zhishan Lin contact

862087343437

linzhsh@sysucc.org.cn

China2 sites, 2 recruiting

  • Li Xu

    Guangzhou, Guangdong, 510060

    Li Xu, MD.,PhD., 862087343582, xuli@sysucc.org.cn

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Li Xu, MD., PhD., 8620-87343115, xuli@sysucc.org.cn

    Zhishan Lin, 8620-87343437, linzhsh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm Phase II Study to Evaluate Camrelizumab in Combination With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with advanced intrahepatic cholangiocarcinoma (ICC).

Read the detailed description

It is estimated that 50 patients who met the study criteria will be enrolled in 3 years and treated with Camrelizumab plus Apatinib in SYSUCC. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.

Being tested
Camrelizumab, Apatinib
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • CamrelizumabDrug

    Also called Camrelizumab for Injection

    Camrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.

  • ApatinibDrug

    Also called Rivoceranib

    Apatinib is a novel angiogenesis inhibitor vascular endothelial growth factor 2.

Study groups in NCT04454905
Study groupRoleWhat they receive
Camrelizumab combination with ApatinibExperimentalCamrelizumab 200mg, every 3 weeks, intravenous infused. Apatinib 250mg, once a day, orally. Until progression or unacceptable toxicity events develop.
Receives: Drug: Camrelizumab; Drug: Apatinib

What is being measured

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

  1. Progression-free Survival (PFS)

    A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.

    Measured: Three years

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

    Measured: Three years

  2. Overall Survival (OS)

    Duration from the date of initial treatment to the date of death due to any cause.

    Measured: Three years

  3. Disease Control Rate (DCR)

    Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

    Measured: Two years

  4. Duration of Response (DoR)

    Duration from the first time reported partial response or complete response to the first time of disease progression or death.

    Measured: Two years

  5. Time to Progression (TTP)

    A duration from the date of initial treatment to disease progression (defined by RECIST 1.1)

    Measured: Two years

  6. Adverse events (AE)

    Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.

    Measured: 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 posted2 Jul 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Jul 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
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454905
Sponsor's protocol ID
B2020-098-01
Status last verified
Apr 2023
First submitted
29 Jun 2020
Last updated
19 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab and Apatinib in people with Intrahepatic Cholangiocarcinoma, run by Sun Yat-sen University 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 6 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?

Results are not available in the source record.

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

Contact Li Xu, MD., PhD. (+862087343582, xuli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Three 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 NCT04454905.

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 19 Apr 2023.

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