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Biliary Tract CancerPhase 2ACABCNCT04642664

Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer

A Phase 2 study testing Apatinib plus Camrelizumab in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Peking Union Medical College Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators design a prospective clinical study to explore the efficacy and safety of apatinib plus camrelizumab in pretreated patients with advanced biliary tract malignant tumors and to analyze potential biomarkers of therapeutic response. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apatinib plus Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesChina
Study dates
1 Dec 2018to 1 Jan 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed cholangiocarcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. Patients with ampullary carcinoma are not eligible.
  • Patients must have failed or are intolerant to one line of systemic chemotherapy treatment.
  • Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0-2.
  • Life expectancy of at least 12 weeks (3 months).
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  • Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.
  • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for alopecia.
  • For patients with advanced biliary tract cancer, liver function status Child-Pugh Class A or B (score<=7).
  • Adequate bone marrow, liver and liver function as assessed by the following laboratory requirements: Total bilirubin ≤ 1.5 x the upper limits of normal (ULN), except for subjects with Gilbert Syndrome who can have bilirubin <3. Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer or stent placement). Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer). Serum creatinine <2 x ULN. Hematologic parameters as follows: Platelet count ≥ 100,000 /mm3. Hemoglobin (Hb) ≥ 9 g/Dl. Absolute neutrophil count (ANC) ≥1000/mm. Blood transfusion to meet the inclusion criteria will be allowed.
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of HCG) performed within24 hours prior to the start of nivolumab Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
  • Patients with history of hepatitis B and hepatitis C will be eligible but patients with hepatitis B must be started on antiviral therapy prior to beginning study therapy
  • Availability of archival tumor tissue for biomarkers analysis (FFPE block or cell block will be required). Specimen from primary site will be allowed. Patients must have at least 10 slides available. Repeat biopsy to obtain sufficient tissue for 10 slides is allowed.

Who cannot join

  • Subjects with active CNS metastases are excluded. If CNS metastases are treated and subjects are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment. Subjects must be off corticosteroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • Child Pugh C disease
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  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • History of allergy or intolerance to study drug components or Polysorbate-80-containing infusions
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.
  • Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of HCG) performed within 24 hours prior to the start of nivolumab and a negative result must be documented before start of treatment.
  • Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
  • Anticancer chemotherapy during the study or within 4 weeks of study enrollment. Subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia). Anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints.
  • Hormonal therapy during the study or within 2 weeks of first study enrollment.
  • Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment.
  • Notably, patients with severe esophageal varices or presented with positive fecal occult blood were also excluded.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)

    Beijing, Beijing Municipality, 100730

  • Hai-Tao Zhao

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer (ACABC): A Prospective Clinical Study

The investigators design a prospective clinical study to explore the efficacy and safety of apatinib plus camrelizumab in pretreated patients with advanced biliary tract malignant tumors and to analyze potential biomarkers of therapeutic response.

Read the detailed description

This was a non-randomized, single institutional, open-label, prospective trial designed to evaluate the efficacy and safety of apatinib in combination with camrelizumab for patients with biliary tract malignant tumors.

It is estimated that 20 patients who met the study criteria will be enrolled in PUMCH and treated with aptinib and camrelizumab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including treatment related adverse events, overall survival and time to progression and objective response. Multi-omics data analysis will be used to find potential biomarkers of treatment response.

Being tested
Apatinib plus Camrelizumab
Keywords
apatinib, camrelizumab, biliary tract cancer, combination immunotherapy
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma

What participants receive

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

  • Apatinib plus CamrelizumabDrug

    Also called Apatinib (Apatinib Mesylate Tablets, Jiangsu Hengrui Medicine, China), Camrelizumab (Carelizumab for Injection, Jiangsu Hengrui Medicine, China)

    Patients received apatinib orally at 250 mg once a day irrespective of the patient weight. During the treatment, apatinib can reduced to half of piece or once every other day considering the grade of treatment related adverse events. Camrelizumab 200 mg was administered intravenously over 30 minutes every 3 weeks. The intermittent period of camrelizumab was no longer than 6 weeks. All patients continued combination treatment until disease progression, unacceptable toxicity, or discontinuation for any reason.

Study groups in NCT04642664
Study groupRoleWhat they receive
Apatinib plus CamrelizumabExperimentalApatinib is a multi-target TKI, which selectively inhibits VEGFR-2. Camrelizumabb is a anti-human PD-1 monoclonal antibody.
Receives: Drug: Apatinib plus Camrelizumab

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 with apatinib plus camrelizumab to disease progression (defined by RECIST 1.1) or death of any cause.

    Measured: Six months

  2. 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: One year

Secondary outcomes (2)

  1. Overall Survival (OS)

    Duration from the date of initial treatment with apatinib plus camrelizumab to the date of death due to any cause

    Measured: Two years

  2. Incidence of Treatment-Emergent Adverse Event

    Any adverse events related with treatment with apatinib plus camrelizumab

    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 posted24 Nov 2020
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2020
  4. Study completion1 Jan 2021

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642664
Sponsor's protocol ID
JS-2160
Acronym
ACABC
Status last verified
Nov 2020
First submitted
22 Nov 2020
Last updated
3 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 21;383(9935):2168-79. doi: 10.1016/S0140-6736(13)61903-0. Epub 2014 Feb 26.

    PubMed 24581682

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PubMed 20375404

  • Scott LJ. Apatinib: A Review in Advanced Gastric Cancer and Other Advanced Cancers. Drugs. 2018 May;78(7):747-758. doi: 10.1007/s40265-018-0903-9.

    PubMed 29663291

  • Hu Y, Lin H, Hao M, Zhou Y, Chen Q, Chen Z. Efficacy and Safety of Apatinib in Treatment of Unresectable Intrahepatic Cholangiocarcinoma: An Observational Study. Cancer Manag Res. 2020 Jul 3;12:5345-5351. doi: 10.2147/CMAR.S254955. eCollection 2020.

    PubMed 32753952

  • Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.

    PubMed 33087333

  • Liu J, Liu Q, Li Y, Li Q, Su F, Yao H, Su S, Wang Q, Jin L, Wang Y, Lau WY, Jiang Z, Song E. Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase II trial. J Immunother Cancer. 2020 May;8(1):e000696. doi: 10.1136/jitc-2020-000696.

    PubMed 32448804

  • Liang L, Wen Y, Hu R, Wang L, Xia Y, Hu C, Qiao Y, Geng X, Chen T, Fei J, Hui K, Jiang X. Safety and efficacy of PD-1 blockade-activated multiple antigen-specific cellular therapy alone or in combination with apatinib in patients with advanced solid tumors: a pooled analysis of two prospective trials. Cancer Immunol Immunother. 2019 Sep;68(9):1467-1477. doi: 10.1007/s00262-019-02375-z. Epub 2019 Aug 27.

    PubMed 31451841

  • Xie L, Xu J, Sun X, Guo W, Gu J, Liu K, Zheng B, Ren T, Huang Y, Tang X, Yan T, Yang R, Sun K, Shen D, Li Y. Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210) for advanced osteosarcoma (APFAO) progressing after chemotherapy: a single-arm, open-label, phase 2 trial. J Immunother Cancer. 2020 May;8(1):e000798. doi: 10.1136/jitc-2020-000798.

    PubMed 32376724

  • Franses JW, Hong TS, Zhu AX. Nivolumab with gemcitabine plus cisplatin for biliary cancers: as easy as ABC? Lancet Gastroenterol Hepatol. 2019 Aug;4(8):575-577. doi: 10.1016/S2468-1253(19)30148-7. Epub 2019 May 17. No abstract available.

    PubMed 31109809

  • Qin S, Ren Z, Meng Z, Chen Z, Chai X, Xiong J, Bai Y, Yang L, Zhu H, Fang W, Lin X, Chen X, Li E, Wang L, Chen C, Zou J. Camrelizumab in patients with previously treated advanced hepatocellular carcinoma: a multicentre, open-label, parallel-group, randomised, phase 2 trial. Lancet Oncol. 2020 Apr;21(4):571-580. doi: 10.1016/S1470-2045(20)30011-5. Epub 2020 Feb 26.

    PubMed 32112738

  • Wang D, Yang X, Long J, Lin J, Mao J, Xie F, Wang Y, Wang Y, Xun Z, Bai Y, Yang X, Guan M, Pan J, Seery S, Sang X, Zhao H. The Efficacy and Safety of Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer: A Prospective Clinical Study. Front Oncol. 2021 Apr 12;11:646979. doi: 10.3389/fonc.2021.646979. eCollection 2021.

    PubMed 33912461

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib plus Camrelizumab in people with Biliary Tract Cancer and Cholangiocarcinoma, run by Peking Union Medical College 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 14 inclusion and 17 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: finished, as of the sponsor's last update on 3 Jun 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free Survival (PFS) (time frame: Six months). 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 NCT04642664, which also lists 11 linked publications.

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 3 Jun 2021.

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