Trial Title:
Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
NCT ID:
NCT06449937
Condition:
Metastatic Colorectal Carcinoma
Multi-organ Metastatic Colorectal Cancer
Metastatic Malignant Neoplasm in the Liver
Conditions: Official terms:
Colorectal Neoplasms
Neoplasms
Immunomodulating Agents
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radical local Surgery
Description:
Radical local resection of liver metastases ( hepatectomy, ablation )
Arm group label:
Group I (Radical local treatment combined with systematic treatment)
Intervention type:
Drug
Intervention name:
Systemic therapy
Description:
Chemotherapy, targeted drug therapy, immunotherapy treatment.
Arm group label:
Group I (Radical local treatment combined with systematic treatment)
Arm group label:
Group II (systematic treatment only or combined with local interventional therapy)
Other name:
Chemotherapy, Cancer, General
Other name:
Targeted therapy
Other name:
immunotherapy
Intervention type:
Other
Intervention name:
Interventional therapy
Description:
Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy
(HAIC)
Arm group label:
Group II (systematic treatment only or combined with local interventional therapy)
Summary:
The purpose of this study was to investigate the effect of only local radical treatment
of liver metastases combined with systematic treatment in the treatment of patients with
multiple organ metastases of colorectal cancer, whether it can benefit the prognosis and
explore the risk factors related to the prognosis.
Detailed description:
Primary objective:
1.To determine the survival benefit of local radical resection of liver metastases in
patients with resectable liver and controllable extrahepatic metastases from colorectal
cancer.
Secondary objectives:
1. To explore the prognosis-related risk factors in patients with colorectal cancer
liver metastases combined with extrahepatic metastases
2. To assess patients' quality-of-life in each treatment group with questionnaires.
3. To evaluate the safety of the treatment in each treatment group.
Grouping Method: Patients are assigned to 1 of 2 groups according to their willingness.
GROUP I: Patients undergo radical local treatment of liver metastases (hepatectomy,
ablation) combined with systemic therapy.
GROUP II: Patients receive Systemic therapy only or combined local interventions (TACE,
HAIC)
Patients are followed up every 3 months up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female, 18-80 years of age.
- Patients volunteered to join the study and signed informed consent, with good
compliance and follow-up.
- Primary colorectal tumors can be radically resected or resected and
histopathologically diagnosed as colorectal cancer.
- Patients with synchronous or metachronous diagnosis of liver metastasis and
extrahepatic metastasis by computed tomography (CT) or magnetic resonance imaging
(MRI).Extrahepatic metastases are stable and controllable as determined by
Multi-disciplinary Treatment (MDT).
- Patients receive only first- or second-line systemic therapy.
- Radical local treatment can be performed after MDT evaluation, and the indications
at least meet the following one:
- Hepatectomy: liver metastases can be completely (R0) removed and required to
retain sufficient functional liver tissue;
- Ablation therapy: The maximum diameter of liver metastases<3 cm, and the
maximum number of ablation ≤ 5.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of at least 3 months.
- Child-Pugh score ≤ 7.
- Laboratory routine examination (blood routine, liver and kidney function,
coagulation function, etc.) no significant abnormalities:
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/l;
- Platelet count (PLT) ≥ 100*10^9/l;
- Hemoglobin ≥ 9g/dl;
- TBIL<1.5 times the upper limit of normal (ULN);
- ALT and AST< 5*ULN;
- Serum creatinine ≤ 1.5 * ULN or Creatinine clearance> 50 ml/min;
- Albumin > 30 g/l.
Exclusion Criteria:
- Patients with only liver metastasis confirmed by CT or MRI.
- History of hepatic encephalopathy or liver transplantation.
- Evidence of brain metastases.
- Pregnant or breast-feeding women.
- History of other malignant tumors (except thyroid cancer and carcinoma in situ) can
be included in the study if the individual has remained disease-free for at least 5
years.
- Patients with acute cardiovascular and cerebrovascular diseases such as acute
cerebral infarction and acute coronary syndrome within 1 month, and the
cardiovascular clinical symptoms or diseases were not well controlled.
- NYHA class 3-4 or left ventricular ejection fraction (LVEF) < 50 % by
echocardiography.
- Uncontrollable hypertension, blood pressure > 160 / 95 mmHg after treatment, history
of hypertensive crisis or hypertensive encephalopathy.
- Uncontrollable infection > grade 2 (NCI-CTC version 5.0).
- Patients with respiratory insufficiency : PaO2 < 60 mmHg at rest , with or without
PaCO2 > 50 mmHg.
- Patients with a large amount of ascites (ultrasound examination showed an echoless
area around the liver and spleen, pelvic cavity, and intestinal loops, and the
mesentery and intestinal canal were seen floating in the echoless area ) or
malignant ascites (cancer cells were found in ascites or ascites CEA was higher than
peripheral blood).
- Coagulation dysfunction ( INR > 1.5 or APTT > 1.5*ULN ), with bleeding tendency.
- Long-term unhealed wounds or fractures, major surgery or severe traumatic injury,
fracture or ulcer occurred within 4 weeks.
- Patients with a history of mental drug abuse and who could not quit or had mental
disorders.
- According to the investigator's judgment, patients with concomitant diseases that
seriously endanger patient safety or affect patient completion of the study.
- According to the investigator's judgment, patients who are not suitable for
inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First People's Hospital of Chu Zhou
Address:
City:
Chuzhou
Zip:
233100
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing-Song Yang, MD
Phone:
+86 13637045768
Email:
yanchen091106@163.com
Facility:
Name:
Fuyang Cancer Hospital
Address:
City:
Fuyang
Zip:
236000
Country:
China
Status:
Recruiting
Contact:
Last name:
Si-Hua Wu, MD
Phone:
+86 13965560586
Email:
wangjoe@ustc.edu.cn
Facility:
Name:
Anhui province hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ji-Zhou Wang, MD PhD
Phone:
13836135864
Email:
wangjoe@ustc.edu.cn
Facility:
Name:
Ma'anshan People's Hospital
Address:
City:
Ma'anshan
Zip:
243000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi-Ming Cao, MD
Phone:
+86 13955577008
Email:
79493183@qq.com
Facility:
Name:
The First Affiliated Hospital of Wannan Medical College
Address:
City:
Wuhu
Zip:
241000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiao-Ming Wang, MD,PhD
Phone:
+86 15922312712
Email:
wxm6901@aliyun.com
Facility:
Name:
The Second People's Hospital of Wuhu
Address:
City:
Wuhu
Zip:
241000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-Zhi Hu, MD
Phone:
+86 18055316877
Email:
wangjoe@ustc.edu.cn
Start date:
July 2024
Completion date:
July 2028
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wannan Medical College
Agency class:
Industry
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06449937
