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Metastatic Colorectal CancerPhase 2NCT03912857

Camrelizumab(SHR-1210) Combined With Apatinib in the Treatment of Advanced Metastatic Colorectal Cancer

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.This study was a one-arm, single-center, open clinical study. A total of 50 patients were enrolled in the study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Dec 2018to 1 Jun 2020
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

  • Subjects voluntarily join the study and sign an informed consent form;
  • Age ≥ 18 years old and ≤ 75 years old, both men and women;
  • Colorectal cancer confirmed by histology or cytology with distant metastasis; confirmed to be a microsatellite stable patient.
  • Previously received single or combined use of oxaliplatin, irinotecan, fluorouracil, second-line and above treatment failure or inability to tolerate second-line and above treatment;
  • For neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months of discontinuation of treatment, it should be counted as first-line treatment failure;
  • According to the solid tumor efficacy evaluation standard (RECIST1.1), at least one measurable lesion, measurable lesions should not have received local treatment such as radiotherapy (target lesions in the previous radiotherapy area, if confirmed to progress, and in line with RECIST1 .1 standard, can also be used as a target lesion.);
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  • Tissue samples should be provided for molecular pathology analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues can provide 10 sheets of 5um thick paraffin sections that are archived and preserved;
  • ECOG: 0 to 1 (see Annex 1);
  • Can swallow pills;
  • Expected survival ≥ 12 weeks;
  • The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks prior to the start of the study):Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;Platelets ≥75×109/L; Hemoglobin ≥ 8g / dL;Serum albumin ≥ 2.8g / dL;Bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN; if there is liver metastasis, ALT and AST ≤ 5 times ULN; Creatinine clearance ≥ 50mL / min (Cockcroft-Gault, see Annex II);

Who cannot join

  • The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituititis, vasculitis) , nephritis, hyperthyroidism, decreased thyroid function; subjects with vitiligo or complete remission in childhood asthma, can be included without any intervention in adults; subjects who require bronchodilators for medical intervention can not be included );
  • Subjects are using immunosuppressive agents, or systemic, or absorbable local hormonal therapies for immunosuppression purposes (dose >10 mg/day of prednisone or other therapeutic hormones) and within 2 weeks prior to enrollment Still continuing to use;
  • Severe allergic reactions to other monoclonal antibodies;
  • Subjects have clinically symptomatic central nervous system metastases (eg, cerebral edema, need for hormonal intervention, or progression of brain metastases). Previously treated with brain or meningeal metastases, such as patients with clinically stable (MRI) who have been on hold for at least 1 month and who have stopped systemic hormonal therapy (dose >10 mg/day of prednisone or other therapeutic hormones) for more than 2 weeks can be included ;
  • Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA class 2 or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular Or ventricular arrhythmia requires treatment or intervention;
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  • abnormal blood coagulation (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency or receiving thrombolysis or anticoagulant therapy;
  • Urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
  • Previously received radiotherapy, chemotherapy, hormonal therapy, surgery or molecular targeted therapy, after the completion of treatment (last dose), subjects less than 4 weeks before the study; adverse events caused by prior treatment (except for hair loss) did not recover To patients with ≤ CTCAE 1 degree;
  • There are significant clinically significant bleeding symptoms within 3 months before randomization or have a clear tendency to hemorrhage, such as gastrointestinal bleeding, active bleeding, baseline fecal occult blood + or above, or vasculitis;
  • Events of arteriovenous thrombosis occurring within 6 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Known hereditary or acquired bleeding and thrombophilia (eg hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.);
  • The subject has an active infection;
  • Subjects with congenital or acquired immunodeficiency (such as HIV-infected patients), or active hepatitis (hepatitis B reference: HBsAg-positive and HBV DNA ≥ 104 copies/ml; hepatitis C reference: HCV antibody-positive);
  • Those who have used other drug clinical trials to study drugs within 4 weeks before the first dose;
  • The subject has had other malignant tumors within 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer);
  • Subjects have previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or have previously received anti-angiogenic drugs (except Avastin);
  • Inoculate a live vaccine within less than 4 weeks of the study or possibly during the study period;
  • At the discretion of the investigator, the subject has other factors that may cause the study to be terminated midway. For example, other serious illnesses (including mental illness) require combined treatment, severe laboratory abnormalities, with family or Factors such as society can affect the safety of the subject.

Trial locations and contacts

1 site in 1 country.

Rui-Hua Xu, PhD contact

+862087342635

lvzd@sysucc.org.cn

shuangzhen chen, PhD contact

13677897211

13640801424@163.com

China1 site, 1 recruiting

  • Cancer center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Rui-Hua Xu, MD, PhD, +862087342635, lvzd@sysucc.org.cn

    Rui-hua Xu, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: A Study of Camrelizumab Combined With Apatinib in the Treatment of Advanced Metastatic Colorectal Cancer:One-arm, Single-center, Open-stage Phase II Clinical

The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.This study was a one-arm, single-center, open clinical study. A total of 50 patients were enrolled in the study.

Read the detailed description

Because of the clinical lack of research to explore the safety and efficacy of VEGFR2 inhibitors in combination with anti-PD-1 antibodies in the treatment of colorectal cancer, we intend to conduct a single-center, one-arm, open, investigator-initiated clinical study aimed at To clarify the efficacy and tolerability of PD-1 antibody SHR-1210 in combination with VEGFR2 inhibitor apatinib in patients with metastatic colorectal cancer microsatellite stabilization, and to explore the tumor tissue and hematological immune molecular markers predicting the effectiveness of the protocol. Things. The results of this clinical trial will likely increase the objective response rate of advanced colorectal cancer after standard treatment, and hopefully find molecular markers that can predict the sensitivity of colorectal cancer PD-1 immunotherapy combined with anti-angiogenic targeted therapy. Therefore, it has important clinical significance.

Being tested
Camrelizumab
Keywords
mCRC MSI-H
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Also called Apatinib

    Experimental: test group Drug:Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.

    Apatinib :250 mg or 375 mg, qd

Study groups in NCT03912857
Study groupRoleWhat they receive
test groupExperimentalDrug:Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg or 375 mg, qd
Receives: Drug: Camrelizumab

What is being measured

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

  1. Objective Response Rates (ORR)

    the ratio of patients who are evaluated as CR or PR

    Measured: up to two year

Secondary outcomes (2)

  1. Duration of remission (DOR)

    Defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death

    Measured: up to two year

  2. Disease Control Rate (DCR)

    It is defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR and SD.

    Measured: up to two year

Timeline

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

  1. First posted11 Apr 2019
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Jun 2020 (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
NCT03912857
Sponsor's protocol ID
PD-1/mCRC
Status last verified
Apr 2019
First submitted
9 Apr 2019
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fasso M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol. 2016 Mar 10;34(8):833-42. doi: 10.1200/JCO.2015.63.7421. Epub 2016 Jan 11.

    PubMed 26755520

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab in people with Metastatic Colorectal Cancer, run by Sun Yat-sen University 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 19 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 16 Apr 2019. 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?

Contact Rui-Hua Xu, PhD (+862087342635, lvzd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rates (ORR) (time frame: up to two year). 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 NCT03912857, which also lists 1 linked publication.

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 16 Apr 2019.

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