Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients

Nanjing NingQi Medicine Science and Technology

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Colon Cancer

Treatments: Drug: Placebo ChangTai Keli; Drug: ChangTai Keli; Drug: mFOLFOX6; Drug: XELOX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02510118

Y0103 (Registry Identifier)

BL2014099-Y0103

Details and patient eligibility

About

The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.

Full description

Although many therapies exist and are being developed to relieve symptoms for colon cancer, there are few randomized controlled clinical trials to evaluate comprehensive Traditional Chinese medicine (TCM) interventions in colon cancer. The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients. This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the synergistic anti-tumor effect of TCM on colon cancer patients. Following a run-in period, approximately 360 subjects will be randomly assigned to conventional chemotherapy treatment group, ChangTai Keli and conventional chemotherapy treatment group for 26 weeks. After the 26 weeks treatment period, subjects in two treatments arms will follow-up 36 months.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy).
2. age > 18 years of age, and the 75 - year - old patient or less;
3. fitness score (ECOG PS) 2 minutes or less, expected lifetime > 6 months;
4. volunteered for the clinical research, and sign the informed consent.

Exclusion criteria

1. patients with other primary malignant tumors within 1 year;
2. intentional, severe liver and kidney disease patients with serious obstacle and function;
3. pregnancy or lactation women, mental disorders to cooperate to complete the healer;
4. is in other subjects or attended other drugs test interval < 3 months.
5. do not meet the inclusion criteria;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 2 patient groups

conventional chemotherapy + placebo ChangTai Keli

Experimental group

Description:

Patients in this group will be given conventional chemotherapy medicine: modified FOLFOX6 (mFOLFOX6) chemotherapy or XELOX recommended by treatment guidelines for colon cancer, and the placebo ChangTai Keli corresponding to the traditional Chinese syndrome of dampness stasis type of spleen deficiency.

Treatment:

Drug: XELOX

Drug: mFOLFOX6

Drug: Placebo ChangTai Keli

conventional chemotherapy + ChangTai Keli

Experimental group

Description:

Patients in this group will be given conventional chemotherapy medicine: modified FOLFOX6 (mFOLFOX6) chemotherapy or XELOX recommended by treatment guidelines for colon cancer, and the ChangTai Keli corresponding to the traditional Chinese syndrome of dampness stasis type of spleen deficiency, a herbal extract twice daily for 26 weeks for lower dosage.

Treatment:

Drug: XELOX

Drug: ChangTai Keli

Drug: mFOLFOX6