Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer

ConditionColon Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-80
SponsorJiangsu Famous Medical Technology Co., Ltd.

About this trial

This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).

Eligibility criteria

Qualifiers

Colon carcinoma confirmed by pathology.*

Completion of surgical resection of tumors with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil (5-FU). *

Within 3 months after the completion of adjuvant chemotherapy.

Patients with Stage IIIB or IIIC disease.*

Disqualifiers

Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.

Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.

Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.

Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.

Trial design

Treatments tested in this trial

  • XLJDOD compound granule
  • placebo (XLJDOD mimetic agent)

Treatment groups

730 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jiangsu Famous Medical Technology Co., Ltd.

Lead sponsor

Jiangsu Province Hospital of Traditional Chinese Medicine

Collaborator

Ministry of Science and Technology of the People´s Republic of China

Collaborator