Local Liver Treatment for Multi-organ Colorectal Cancer Metastases

NCT06449937 | Recruiting DMC

• 1 other identifier: 2024KY109
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Metastatic Colorectal Carcinoma; Multi-organ Metastatic Colorectal Cancer; Metastatic Malignant Neoplasm in the Liver

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Differences in overall survival between the two arms were assessed using the log-rank test; Cox proportional hazards regression models were used to determine the factors and hazard ratios associated with overall survival.

  From date of study inclusion until the date of death or or the date of last follow-up, assessed up to 2 years

Secondary Outcomes (3)

• Liver-specific progression free survival rates

  Date of study inclusion to until local recurrence or progression in the liver or death from any cause, assessed up to 2 years

• Incidence of adverse events

  Assessed up to 2 years

• Quality of life scores-EORTC QLQ-C30 (version 3) questionnaire

  Assessed up to 2 years

Study Arms (2)

Group I (Radical local treatment combined with systematic treatment)

EXPERIMENTAL

Patients undergo radical local treatment of liver metastases (hepatectomy, ablation) combined with systematic treatment.

Procedure: Radical local Surgery; Drug: Systemic therapy

Group II (systematic treatment only or combined with local interventional therapy)

ACTIVE COMPARATOR

Patients undergo systemic therapy only or combined with local interventional therapy (TACE, HAIC).

Drug: Systemic therapy; Other: Interventional therapy

Interventions

Radical local Surgery PROCEDURE

Radical local resection of liver metastases ( hepatectomy, ablation )

Group I (Radical local treatment combined with systematic treatment)

Systemic therapy DRUG

Chemotherapy, targeted drug therapy, immunotherapy treatment.

Also known as: Chemotherapy, Cancer, General, Targeted therapy, immunotherapy

Group I (Radical local treatment combined with systematic treatment); Group II (systematic treatment only or combined with local interventional therapy)

Interventional therapy OTHER

Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)

Group II (systematic treatment only or combined with local interventional therapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• First Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (6)

The First People's Hospital of Chu Zhou

Chuzhou, Anhui, 233100, China

RECRUITING

Fuyang Cancer Hospital

Fuyang, Anhui, 236000, China

RECRUITING

Anhui province hospital

Hefei, Anhui, 230000, China

RECRUITING

Ma'anshan People's Hospital

Ma’anshan, Anhui, 243000, China

RECRUITING

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

RECRUITING

The Second People's Hospital of Wuhu

Wuhu, Anhui, 241000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Ji-Zhou Wang, MD PhD

  Anhui province hospital

  STUDY DIRECTOR

• Xiao-Ming Wang, MD PhD

  First Affiliated Hospital of Wannan Medical College

  PRINCIPAL INVESTIGATOR

• Yu-Zhi Hu, MD

  The Second People&amp;amp;#39;s Hospital of Wuhu

  PRINCIPAL INVESTIGATOR

• Yi-Ming Cao, MD

  Ma&amp;amp;#39;anshan People&amp;amp;#39;s Hospital

  PRINCIPAL INVESTIGATOR

• Qing-Song Yang, MD

  The First People&amp;amp;#39;s Hospital of Chu Zhou

  PRINCIPAL INVESTIGATOR

• Si-Hua Wu, MD

  Fuyang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-Zhou Wang, MD PhD

CONTACT

+86 13836135864; wangjoe@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)