Camrelizumab Combined With Apatinib 、XELOX 、RFA in the Treatment of Liver Metastases of Colorectal Cancer

Last updated: April 14, 2020
Sponsor: Zhongshan Hospital Xiamen University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT04202978
Arise-FJ-R002
  • Ages 18-75
  • All Genders

Study Summary

To evaluate the safety of karillizumab combined with apatinib mesylate, XELOX and radiofrequency ablation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 - 75 years

  • Confirmed by pathology (including histology or cytology) as metastatic colorectaladenocarcinoma of the liver (no other metastatic sites)

  • Confirmed by CT/MRI/PET - CT/ultrasound examination of liver metastases, the livermetastases number 3 or higher, and the multidisciplinary team (MDT) confirmed forunresectable liver metastases;

  • Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 (CT scan length and diameter of tumor lesion≥10mm,CT scan of lymph node lesion wasshort diameter≥15mm,scan slice thickness 5mm;)

  • ECOG(Eastern Cooperative Oncology Group)PS(Performance Status):0-2 scores

  • The expected survival time is more than 3 months

  • The main organ function is normal, which should meet the following criteria:

(1) blood routine examination standards should be met(no blood transfusion within 14days) a.HB≥ 90g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L (2)biochemicalexamination shall comply with the following criteria:

  1. BIL<1.5 normal upper limit ULN

  2. ALT and AST≤5 ULN

  3. Cr≤1.5 ULN,CCR(creatinine clearance rate)≥50ml/min(Cockcroft-Gault formula)

  • Women of childbearing age must have a pregnancy test in 7 days before entering thegroup (in serum), and the results were negative, and willing to use appropriatecontraception during the study period and the last 8 weeks after giving drug test; menshould have the surgical sterilization, or adopt the appropriate contraceptive methodsduring the test and the last 8 weeks after giving drug test。

  • Participants is willing to participate in this study, sign the informed consent, havegood compliance, cooperate with follow-up.

Exclusion

Exclusion Criteria:

  • Participants is willing to participate in this study, sign the informed consent, havegood compliance, cooperate with follow-up.

  • Any other malignancy was diagnosed within the first 5 years of the study, exceptlocally treatable and cured basal cell or squamous cell carcinoma of the skin,superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of thebreast duct, and papillary carcinoma of the thyroid.

  • Patients who had received anti-tumor therapy, including chemotherapy, radiotherapy,surgery, endocrine therapy, biological therapy, tumor embolization, targeted therapyand immunotherapy (pd-1 / pd-l1 antibody, anti-pd-l2 antibody, anti-cd137 antibody,ctla-4 antibody, or other drugs/antibodies acting on T cell co-stimulation orcheckpoint pathway) within 28 days before enrollment.

  • Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease;obstruction of the digestive tract with severe infection.

  • Distant metastases to sites other than the liver.

  • The blood pressure of patients with hypertension cannot be reduced to the normal rangeby the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90mmHg)

  • Patients have a clear tendency with gastrointestinal bleeding, including the followingsituation: local active ulcerative lesions, and fecal occult blood (+ +); with melenaand hematemesis history in 2 months; and patients with fecal occult blood (+) andunresected gastric primary tumor; patients with the risk of bleeding should take thegastroscopy test, if it is the gastric cancer, and researchers believe that mayresults in massive digestive tract hemorrhage;coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastintime)>1.5 ULN), with bleeding tendency

  • pregnant or lactating women

  • A history of immunodeficiency, including HIV testing positive, or other acquired orcongenital immunodeficiency disorders, or a history of organ transplantation andallogeneic bone marrow transplantation

  • Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolledsystemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acutepneumonia)

  • Patients are positive of urine protein (urine protein detection 2+ or above, or 24hours urine protein quantitative >1.0g)

  • Patients with a history of cardiovascular and cerebrovascular diseases who are stilltaking oral thrombolytic drugs or anticoagulant drugs

  • Patients with uncontrolled epilepsy, central nervous system disease, or mentaldisorders whose clinical severity, as determined by the investigator, may prevent thesigning of the informed consent or have multiple factors that affect oral medications (such as inability to swallow, persistent uncontrolled nausea and vomiting, chronicdiarrhea, and intestinal obstruction)

  • A person who has previously been allergic to any component of camrilizumab or to anycomponent of the drug under study

  • Patients who participate in other clinical studies before or during treatment

  • The researchers consider those who were not suitable for inclusion

Study Design

Total Participants: 23
Study Start date:
March 01, 2020
Estimated Completion Date:
November 01, 2021

Study Description

To evaluate the safety of karillizumab combined with apatinib mesylate, XELOX and radiofrequency ablation.

The 23 patients were enrolled in a 3-week regimen with 200mg Camrelizumab given intravenously every 3weeks and 250mg apatinib mesylate qd ,and 850mg/m2 capecitabine d1-14 and 130mg/m2 oxaliplatin given intravenously d1.

Connect with a study center

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian 361000
    China

    Active - Recruiting

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