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Metastatic Colorectal CarcinomaNCT06449937

Local Liver Treatment for Multi-organ Colorectal Cancer Metastases

A study testing Radical local Surgery, Systemic therapy and Interventional therapy in people with Metastatic Colorectal Carcinoma and Multi-organ Metastatic Colorectal Cancer, run by Anhui Provincial Hospital at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Radical local Surgery, Systemic therapy and Interventional therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
6 sitesChina
Study dates
Jul 2024to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ji-Zhou Wang, MD PhD contact

+86 13836135864

wangjoe@ustc.edu.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • The First People's Hospital of Chu Zhou

    Chuzhou, Anhui, 233100

    Qing-Song Yang, MD, +86 13637045768, yanchen091106@163.com

    Recruiting

  • Fuyang Cancer Hospital

    Fuyang, Anhui, 236000

    Si-Hua Wu, MD, +86 13965560586, wangjoe@ustc.edu.cn

    Recruiting

  • Anhui province hospital

    Hefei, Anhui, 230000

    Ji-Zhou Wang, MD PhD, 13836135864, wangjoe@ustc.edu.cn

    Recruiting

  • Ma'anshan People's Hospital

    Ma’anshan, Anhui, 243000

    Yi-Ming Cao, MD, +86 13955577008, 79493183@qq.com

    Recruiting

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

    Xiao-Ming Wang, MD,PhD, +86 15922312712, wxm6901@aliyun.com

    Recruiting

  • The Second People's Hospital of Wuhu

    Wuhu, Anhui, 241000

    Yu-Zhi Hu, MD, +86 18055316877, wangjoe@ustc.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Analysis of the Efficacy of Local Liver Treatment for Multi-organ Colorectal Cancer Metastases: A Prospective, Multicenter, Non-randomized Concurrent Controlled Study

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.

Read the 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.

Being tested
Radical local Surgery, Systemic therapy, Interventional therapy
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Radical local SurgeryProcedure or surgery

    Radical local resection of liver metastases ( hepatectomy, ablation )

  • Systemic therapyDrug

    Also called Chemotherapy, Cancer, General, Targeted therapy, immunotherapy

    Chemotherapy, targeted drug therapy, immunotherapy treatment.

  • Interventional therapyOther

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

Study groups in NCT06449937
Study groupRoleWhat they receive
Group I (Radical local treatment combined with systematic treatment)ExperimentalPatients undergo radical local treatment of liver metastases (hepatectomy, ablation) combined with systematic treatment.
Receives: Procedure: Radical local Surgery; Drug: Systemic therapy
Group II (systematic treatment only or combined with local interventional therapy)Active comparatorPatients undergo systemic therapy only or combined with local interventional therapy (TACE, HAIC).
Receives: Drug: Systemic therapy; Other: Interventional therapy

What is being measured

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

  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.

    Measured: 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)

  1. Liver-specific progression free survival rates

    The Kaplan-Meier method will be used to estimate time to intrahepatic recurrence or progression or death from any cause in patients.

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

  2. Incidence of adverse events

    Record the frequency and percentage of adverse events, their grade, and their relationship to radical local treatment.

    Measured: Assessed up to 2 years

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

    Summarized using descriptive statistics, including mean, standard deviation, median and range.

    Measured: Assessed up to 2 years

Timeline

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

  1. First posted10 Jun 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449937
Sponsor's protocol ID
2024KY109
Status last verified
Jun 2024
First submitted
4 Jun 2024
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radical local Surgery, Systemic therapy and Interventional therapy in people with Metastatic Colorectal Carcinoma and Multi-organ Metastatic Colorectal Cancer, run by Anhui Provincial Hospital at 6 sites 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 19 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: looking for participants now, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ji-Zhou Wang, MD PhD (+86 13836135864, wangjoe@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From date of study inclusion until the date of death or or the date of last follow-up, assessed up to 2 years). 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 NCT06449937.

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 10 Jun 2024.

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