Hepatic Metastasis of Colorectal CancerPhase 1/2NCT04202978
Camrelizumab Combined With Apatinib 、XELOX 、RFA in the Treatment of Liver Metastases of Colorectal Cancer
A Phase 1/2 study testing Camrelizumab, Apatinib Mesylate and Capecitabine in people with Hepatic Metastasis of Colorectal Cancer, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
To evaluate the safety of karillizumab combined with apatinib mesylate, XELOX and radiofrequency ablation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Metastasis of Colorectal Cancer
- What is being tested?
- Camrelizumab, Apatinib Mesylate and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Nov 2021
- Phase
- Phase 1/2
- 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
- Age 18 - 75 years
- Confirmed by pathology (including histology or cytology) as metastatic colorectal adenocarcinoma of the liver (no other metastatic sites)
- Confirmed by CT/MRI/PET - CT/ultrasound examination of liver metastases, the liver metastases number 3 or higher, and the multidisciplinary team (MDT) confirmed for unresectable 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 was short 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
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- The main organ function is normal, which should meet the following criteria:
- blood routine examination standards should be met（no blood transfusion within 14 days）
- a．HB≥ 90g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L （2）biochemical examination shall comply with the following criteria：
- BIL<1.5 normal upper limit ULN
- ALT and AST≤5 ULN
- 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 the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test。
- Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
Who cannot join
- Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
- Any other malignancy was diagnosed within the first 5 years of the study, except locally 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 the breast 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 therapy and 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 or checkpoint 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 range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg)
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- Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage；coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency
- pregnant or lactating women
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation
- Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia)
- Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g)
- Patients with a history of cardiovascular and cerebrovascular diseases who are still taking oral thrombolytic drugs or anticoagulant drugs
- Patients with uncontrolled epilepsy, central nervous system disease, or mental disorders whose clinical severity, as determined by the investigator, may prevent the signing of the informed consent or have multiple factors that affect oral medications (such as inability to swallow, persistent uncontrolled nausea and vomiting, chronic diarrhea, and intestinal obstruction)
- A person who has previously been allergic to any component of camrilizumab or to any component 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361000
Wu wei xin, Doctor, 13950103647 ext. 0592, wu3175036@163.com
About this study
Official title: Camrelizumab Combined With Apatinib 、XELOX 、RFA in the Treatment of Liver Metastases of Colorectal Cancer: One-arm Exploratory Clinical Study
To evaluate the safety of karillizumab combined with apatinib mesylate, XELOX and radiofrequency ablation
Read the detailed 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.
- Conditions
- Hepatic Metastasis of Colorectal Cancer
- Being tested
- Camrelizumab, Apatinib Mesylate, Capecitabine, Oxaliplatin, radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab ：200mg intravenous injection d1 q3w
Apatinib MesylateDrug
Apatinib：250mg/d P.O ,qd ,3weeks
CapecitabineDrug
capecitabine:850mg/m2 P.O ,bid ,d1-d14
OxaliplatinDrug
oxaliplatin:130mg/m2 intravenous injection d1 q3w
radiofrequency ablationRadiation
radiofrequency ablation:between first cycle and second cycle percutaneous
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+ Apatinib +XELOX +RFA | Experimental | Camrelizumab combined with Apatinib 、XELOX 、RFA in the treatment of liver metastases of colorectal cancer Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
The surgical procedure was total or subtotal proctectomy and hepatectomy with 4 cycles after Conversion therapy
Measured: 6 months
Secondary outcomes (2)
Objective response rate
Objective response rate according to Response Evaluation Criteria in Solid Tumours(RECIST)1.1
Measured: 6 months
pathologic complete response
pathologic complete response (pCR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Mar 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Metastasis of Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202978
- Sponsor's protocol ID
- Arise-FJ-R002
- Status last verified
- Feb 2020
- First submitted
- 13 Dec 2019
- Last updated
- 16 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Apatinib 、XELOX 、RFA in the Treatment of Liver Metastases of Colorectal Cancer: One-arm Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT04202978
- Acronym / sponsor ID
- Arise-FJ-R002
- Conditions
- Hepatic Metastasis of Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of karillizumab combined with apatinib mesylate, XELOX and radiofrequency ablation
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+ Apatinib +XELOX +RFA | Experimental | Drug: Camrelizumab, Drug: Apatinib Mesylate, Drug: Capecitabine, Drug: Oxaliplatin, Radiation: radiofrequency ablationCamrelizumab combined with Apatinib 、XELOX 、RFA in the treatment of liver metastases of colorectal cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 - 75 years
- Confirmed by pathology (including histology or cytology) as metastatic colorectal adenocarcinoma of the liver (no other metastatic sites)
- Confirmed by CT/MRI/PET - CT/ultrasound examination of liver metastases, the liver metastases number 3 or higher, and the multidisciplinary team (MDT) confirmed for unresectable 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 was short diameter≥15mm，scan slice thickness 5mm；）
- ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-2 scores
Key exclusion criteria (16 listed)
- Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
- Any other malignancy was diagnosed within the first 5 years of the study, except locally 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 the breast 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 therapy and 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 or checkpoint 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamrelizumabCamrelizumab ：200mg intravenous injection d1 q3w | Drug | Camrelizumab+ Apatinib +XELOX +RFA |
| Apatinib MesylateApatinib：250mg/d P.O ,qd ,3weeks | Drug | Camrelizumab+ Apatinib +XELOX +RFA |
| Capecitabinecapecitabine:850mg/m2 P.O ,bid ,d1-d14 | Drug | Camrelizumab+ Apatinib +XELOX +RFA |
| Oxaliplatinoxaliplatin:130mg/m2 intravenous injection d1 q3w | Drug | Camrelizumab+ Apatinib +XELOX +RFA |
| radiofrequency ablationradiofrequency ablation:between first cycle and second cycle percutaneous | Radiation | Camrelizumab+ Apatinib +XELOX +RFA |
Primary outcome
R0 resection rate
Time frame: 6 months
The surgical procedure was total or subtotal proctectomy and hepatectomy with 4 cycles after Conversion therapy
2 secondary outcomes
Objective response rate
Time frame: 6 months
pathologic complete response
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Camrelizumab, Apatinib Mesylate and Capecitabine in people with Hepatic Metastasis of Colorectal Cancer, run by Zhongshan Hospital Xiamen 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 14 inclusion and 16 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 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wu wei xin, doctor (13950103647 ext. 0592, wu3170536@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2020.