Combining Chinese herbal medicine formula with standard chemotherapy and Molecular Targeted Therapy in patients with metastatic colorectal cancer(mCRC): a multi-institutional, randomised, double-blinded, placebo controlled trial

Phase 1

Recruiting

• Conditions: Metastatic colon carcinoma

• Registration Number: ITMCTR2100004597
• Lead Sponsor: Hospital Of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Sign the informed consent form voluntarily;
2. For colon or rectal adenocarcinoma confirmed by histology, refer to the 2019.1 edition of NCCN Colon Cancer Clinical Practice Guidelines, and evaluate as inoperable locally advanced, recurrent or metastatic subjects of stage IIIB-IV;
3. Within 28 days of the first study medication, it is confirmed by imaging that there are measurable lesions defined by the RECIST 1.1 standard;
4. The subject has not received any systemic anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy, biological or hormone therapy, and has not received any VEGFR inhibitor treatment in the past 4 weeks;
5. No surgery or major biopsy within 4 weeks after random assignment;
6. Aged >= 18 years old and <= 75 years old, weight >= 40Kg, no gender limit;
7. Subjects have no heart, liver, kidney and hematopoietic system dysfunction; the definition is as follows: absolute neutrophil count (ANC) > 1.5 x 10^9/L; platelets > 100 x 10^9/L; hemoglobin >= 90g/L; Total bilirubin <= 1.5 x upper limit of normal (ULN); AST(SGOT) or ALT(SGPT) <= 2.5 x upper limit of normal, if it is clearly attributed to liver metastasis, < 5 times the upper limit of normal; UPCR < 1.0;
8. Physical condition score ECOG score <= 2 points, KPS >= 50 points;
9. Estimated survival time >= 12 weeks;
10. Women must meet one of the following conditions:
(1) Surgical sterilization has been performed;
(2) Patients who have been menopausal, menopause for at least 1 year
(3) With fertility, the following conditions must be met:
Serum/urinary pregnancy test results were negative before enrollment; during the entire study period to 6 months after the last medication, they agreed to adopt an approved method of contraception.
Males must meet one of the following conditions:
(1) Surgical sterilization has been performed;
(2) A recognized method of contraception must be used during the entire study period to 6 months after the last medication.

Exclusion Criteria

1.Histologically confirmed mixed adenosquamous carcinoma with squamous cells as the main component (squamous cell carcinoma accounted for >= 10%);
2.Other malignant tumors that have occurred or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors.
3.Subjects who confirmed HCV-positive, HIV-positive, syphilis test-positive, or HBsAg-positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test >= 10^3 copies/mL or >= 2000IU/mL during the screening period;
4.Past hypertensive crisis, history of hypertensive encephalopathy, or uncontrolled hypertension (after taking antihypertensive drugs, systolic blood pressure > 150mmHg, or diastolic blood pressure > 100mmHg);
5.Cardiovascular diseases of clinical significance, including but not limited to transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), unstable angina, and New York Heart Association classification >= Grade II congestive heart failure, severe arrhythmia that cannot be controlled by drugs;
6.Those who are known to be allergic to the study drug;
7.Palliative radiotherapy was performed on bone lesions other than the chest within 2 weeks before the first study medication;
8.Subjects with known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, or leptomeningeal disease;
9.In the past 4 weeks or are participating in other clinical trials;
10.The expected survival period is less than 12 weeks;
11.People with a history of mental illness that is difficult to control;
12.Did not recover from the toxicity of previous anti-cancer therapy (NCICTCAE level 1, including oxaliplatin-induced alopecia and neurotoxicity <= level 2), did not fully recover from previous surgery, or previous anti-cancer therapy or surgery Less than 4 weeks;
13.Active infections that are not clinically controlled, such as acute pneumonia;
14.Dysphagia, non-chemotherapy-related vomiting or drug malabsorption;
15.Coagulation dysfunction, bleeding tendency or obvious bleeding history after receiving anticoagulant therapy;
16.Arterial/venous thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks) occurred within 12 months before the first treatment.
17. The fracture or wound has not been cured for a long time.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS);

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS);Clinical evaluation of nausea-vomiting-anorexia complex symptom group after chemotherapy;Objective Response Rate (ORR);Clinical evaluation of cachexia;