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Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

ConditionsColorectal CancerChemotherapy EffectSurgeryMetastasisSurvival
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;

Aged 18-75 years;

Male or non-pregnant or lactating women;

Pathological diagnosis of colorectal adenocarcinoma;

Disqualifiers

A history of other malignant tumors within 5 years;

Distant metastasis found during surgery;

Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;

Suffering from epilepsy or other mental illness, unable to control behavior;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mitomycin

    Drug

    Mitomycin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

  • Lobaplatin

    Drug

    Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Lobaplatin 50mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Treatment groups

201 Participants
are divided into 3 treatment groups
Group A: Drug group 1Experimental treatment 1 intervention
Group B: Drug group 2Experimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

peritoneal metastasis

peritoneal metastasis-free survival (pRFS)

Time frame
3-year
2

overall survival

overall survival (OS)

Time frame
3-year

Secondary outcomes

1

Number of participants with immunosuppression events as assessed by blood immunological indicators

Before and After Hyperthermic Intraperitoneal Chemotherapy, collect 5mL blood samples of patients for detecting immunological indicators such as CD3, CD4 and CD8 lymphocyte population; Interferon-γ; tumor necrosis factor (TNF)-α; interleukin-2, 4, 8, 10, etc

Time frame
up to 4 weeks
2

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

postoperative adverse events (referring to CTCAE 5.0 \[including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events\]) was analyzed

Time frame
up to 4 weeks
3

The positive rate of cancer cells of participants by exfoliative cytology examination

According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed.

Time frame
1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: