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NCT07913516
NA

Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer

Sponsor: Huanfang Fan

View on ClinicalTrials.gov

Summary

This is a single-center, prospective, open-label, single-arm feasibility study. Thirty-five patients with stage IIIB-IV colorectal adenocarcinoma undergoing capecitabine monotherapy will be enrolled. All participants will receive oral capecitabine (1250 mg/m2, twice daily, 14 days on/7 days off, 21-day cycle, up to 8 cycles) combined with Huangqi Yangyuan Formula (a Chinese herbal decoction, 150 mL twice daily). The primary objective is to evaluate the completion rate of standardized capecitabine chemotherapy at 4 and 8 cycles. Secondary outcomes include chemotherapy-related adverse events (CTCAE v5.0), quality of life (EORTC QLQ-C30), traditional Chinese medicine constitution scores (BCQ), disease-free survival at 3-month follow-up, peripheral blood T-lymphocyte subsets, and safety laboratory indicators.

Official title: A Prospective Single-Arm Feasibility Clinical Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Patients With Advanced Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2027-01-01

Completion Date

2029-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Capecitabine

Oral capecitabine at 1250 mg/m2 twice daily, taken within 30 minutes after meals, days 1-14 followed by 7 days rest per 21-day cycle, for up to 8 cycles. Dose adjustments are permitted per clinical guidelines based on toxicity.

OTHER

Huangqi Yangyuan Formula (Chinese Herbal Decoction)

A nine-herb Chinese medicinal decoction prepared in-house, including Radix Astragali (Huang Qi), Radix Rehmanniae Preparata (Shu Di Huang), and seven additional herbs. Each dose is 150 mL, administered orally twice daily, taken 30 minutes apart from capecitabine. Treatment starts at cycle 1 and continues through 8 cycles, with a 1-week interruption at the end of cycle 4.

Locations (1)

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei Provincial, China