Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

NCT ID: NCT05774964

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-03-15

Brief Summary

The aim of this study is to explore the therapeutic effect of Quintuple method in the treatment of patients with multiple and refractory liver metastases from colorectal cancer. A randomized single-arm clinical trial was conducted.The intervention group was treated with single SOX chemotherapy, SOX chemotherapy combined with cetuximab targeted therapy, SOX chemotherapy combined with low-dose cetuximab targeted therapy combined with three-drug regimen（Quintuple method）, and the RECIST 1.1 solid tumor evaluation criteria were used to assess the disease.

Detailed Description

Patients with inoperable colorectal liver metastases were selected for genetic testing and enrolled if Kras/Nras/Braf wild-type was detected. The enrolled patients were randomly divided into three groups, in which patients in the single chemotherapy group were treated with SOX regimen alone for chemotherapy;patients in the chemotherapy targeted group were treated with SOX regimen chemotherapy combined with cetuximab targeted therapy; patients in the Quintuple method group were treated with SOX regimen chemotherapy,cetuximab targeted therapy and folic acid, vitamin A, and metronidazole three-drug regimen. Specific drugs were administered at the following doses: SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and S1 orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area. Metronidazole 0.4 g/time, qd; vitamin A 5,000 units/time, qd; folic acid 5 mg/time, qd. The latter three drugs were continued until the end of all chemotherapy cycles.Tumor markers associated with liver metastases from colorectal cancer,including magnetic resonance imaging and computed tomography, wererepeated every 3 months and disease was assessed using RECIST 1.1 criteria for the evaluation of solid tumors. The primary end point was death, and the secondary end point was disease progression.

Conditions

For Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple Method

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy alone group

Patients treated with chemotherapy using SOX regimen alone. SOX regimen every 3 weeks,oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area

S1

Intervention Type: DRUG

Orally on d2-d15 at 20 mg three times daily

Chemotherapy targeted group

Patients treated with cetuximab targeted therapy in combination with chemotherapy using SOX regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously,once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area

S1

Intervention Type: DRUG

Orally on d2-d15 at 20 mg three times daily

Cetuximab

Intervention Type: DRUG

Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Quintuple method group

Patients treated with a combination of SOX regimen, cetuximab, and folic acid, vitamin A, and metronidazole three-drug regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously,once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area. Metronidazole 0.4g/time, qd;vitamin A 5,000 units/time, qd; folic acid 5 mg/time,qd. The latter three drugs were continued until the end of all chemotherapy cycles.

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area

S1

Intervention Type: DRUG

Orally on d2-d15 at 20 mg three times daily

Cetuximab

Intervention Type: DRUG

Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Metronidazole

Intervention Type: DRUG

Metronidazole 0.4g/time, qd

Vitamin A

Intervention Type: DRUG

Vitamin A 5,000 units/time, qd

Folic acid

Intervention Type: DRUG

Folic acid 5 mg/time, qd

Interventions

Oxaliplatin

Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area

Intervention Type: DRUG

S1

Orally on d2-d15 at 20 mg three times daily

Intervention Type: DRUG

Cetuximab

Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Intervention Type: DRUG

Metronidazole

Metronidazole 0.4g/time, qd

Intervention Type: DRUG

Vitamin A

Vitamin A 5,000 units/time, qd

Intervention Type: DRUG

Folic acid

Folic acid 5 mg/time, qd

Intervention Type: DRUG

Other Intervention Names

Tegafur,Gimeracil and Oteracil Porassium Capsules

Eligibility Criteria

Inclusion Criteria

1. Aged 18-80 years at the time of signing the informed consent form;

2. Patients with histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);

3. Patients with liver metastases found by imaging examination, and liver metastases cannot be radically resected, Or relapse liver metastasis;

4. At least one measurable metastatic lesion as defined by RECIST version 1.1;

5. Genetic test results are Kras/Nras/Braf wild-type or mutation type;

6. ECOG performance status 0-1;

7. Except for the liver, other organs function well;

8. Willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures.

Exclusion Criteria

1. Patients with non-primary intestinal cancer;

2. Patients whose primary tumor as well as metastases can be radically resected by surgery;

3. One or several serious allergies to each drug required for the trial;

4. Combined with respiratory, circulatory, urinary, hematopoietic and other serious underlying diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

Countries

China

Central Contacts

Zhang Zhongguo, Doctor

Role: CONTACT

Zhangzhongguoln@163.com

15840217908

Yang Xiaoyu, Doctor

Role: CONTACT

yangxiaoyu1368@163.com

18900918453

Other Identifiers

20230303zzg

Identifier Type: -

Identifier Source: org_study_id