An interventional study of Capecitabine and Huangqi Yangyuan Formula (Chinese Herbal Decoction) in Advanced Colorectal Cancer and Capecitabine-Related Adverse Reaction, sponsored by Huanfang Fan. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Huanfang Fan · Not applicable, Interventional, and Supportive care
Among 179 studies testing capecitabine in Colorectal Neoplasms — 24 open to participants now, 32 under way, 7 of them phase 3. Capecitabine · Colorectal Neoplasms.
Among the 179 studies testing capecitabine in Colorectal Neoplasms, this one is the 123rd largest by planned enrollment of the 173 interventional ones that give a count, is the only one that started in 2027, is one of 4 with no phase, reaches primary completion later than 26 of the 31 other live ones, and was the 178th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →24 of the 179 studies testing capecitabine in Colorectal Neoplasms are open now, in 9 countries. Recruiting first, the newest first:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
Gruppo Oncologico del Nord-Ovest · Sites in France, Germany, Italy and 1 more country
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 18+
Nizhny Novgorod Regional Clinical Oncology Center · Sites in Russian Federation
Ages 70–90
Henry Ford Health System · Sites in United States
Ages 18+
By country, each count listing its studies:
Capecitabine: first FDA approval 1998 (XELODA), first EMA approval 2001. What it is approved for, and how studies give it, is on its page →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
179 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 30 · Phase 2 124 · Phase 3 37 · Phase 4 8
First in 1998; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 35 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 55 across the 173 interventional studies. Of the 111 that completed or were terminated, 36 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 179 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Huanfang Fan as lead sponsor.
Huanfang Fan has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
9 of the studies testing capecitabine in Colorectal Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05700656The Netherlands Cancer InstituteGalunisertib Combined With Capecitabine in Advanced CRC With PM | 2026-12 |
| NCT06065371Henry Ford Health SystemSacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy | 2026-12 |
| NCT07229846Yanqiao ZhangA Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation | 2027-02 |
| NCT07570914Tianjin Medical University Cancer Institute and HospitalHepatic Arterial Infusion of Liposomal Irinotecan Plus Oxaliplatin and Capecitabine as Adjuvant Therapy for Colorectal Cancer Liver Metastases | 2027-05-30 |
| NCT07051785Liu HuangFruquintinib vs Bevacizumab Combined With Irinotecan Liposome and Capecitabine as Second-Line Therapy for Advanced Metastatic Colorectal Cancer | 2027-07-06 |
Among the 179 studies testing capecitabine in Colorectal Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Advanced colorectal cancer (CRC) is commonly treated with capecitabine monotherapy. However, capecitabine frequently causes hand-foot syndrome, diarrhea, fatigue, myelosuppression, and gastrointestinal adverse events, which may lead to dose reduction, treatment interruption, or discontinuation. Traditional Chinese medicine (TCM) holds that patients undergoing chemotherapy present a pattern of spleen-kidney deficiency with toxic heat accumulation. Huangqi Yangyuan Formula is a nine-herb Chinese medicinal decoction designed to invigorate spleen and kidney, supplement qi, clear cancer toxins, and resolve stasis. Preliminary pharmacological evidence suggests its components may exert anti-tumor, immunomodulatory, and chemo-protective effects. This study aims to assess the feasibility and preliminary safety of combining Huangqi Yangyuan Formula with capecitabine chemotherapy in 35 patients with advanced CRC. Participants will be followed for 8 chemotherapy cycles (approximately 6 months) plus a 3-month post-treatment follow-up. The study will provide feasibility data to inform the design of a future large-scale randomized controlled trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive capecitabine monotherapy (1250 mg/m2, orally, twice daily, days 1-14 of each 21-day cycle, up to 8 cycles) combined with Huangqi Yangyuan Formula (Chinese herbal decoction, 150 mL per dose, twice daily, taken 30 minutes apart from capecitabine, starting from cycle 1; discontinued for 1 week at the end of cycle 4).
Drug: Capecitabine · Other: Huangqi Yangyuan Formula (Chinese Herbal Decoction)
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.
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.
Completion Rate of Standardized Capecitabine Chemotherapy
Proportion of participants completing 4 cycles and 8 cycles of capecitabine chemotherapy without treatment discontinuation or major dose reduction.
Time frame: At the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Incidence and Grade of Chemotherapy-Related Adverse Events
Adverse events graded according to CTCAE version 5.0, including diarrhea, hand-foot reaction, myelosuppression, fatigue, gastrointestinal symptoms, and hepatic/renal toxicity.
Time frame: At the baseline, at the end of every 2 chemotherapy cycles (each cycle lasting 28 days), and at the end of the third month after the treatment was completed.
Quality of Life Score (EORTC QLQ-C30)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) total score and subscale scores. Score range: 0-100. Higher scores represent better quality of life for the global health status/QoL scale and functional scales; higher scores represent worse symptoms for symptom subscales.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Traditional Chinese Medicine Constitution Score
BCQ (Body Constitution Questionnaire) scores for qi deficiency, blood deficiency, and yang deficiency.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Disease-Free Survival Rate
Proportion of participants alive and progression-free at 3 months after completion of chemotherapy
Time frame: At the end of the third month after the completion of chemotherapy.
Peripheral Blood T-Lymphocyte Subsets
Absolute counts and ratios of CD3+, CD4+, and CD8+ T cells measured by flow cytometry.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Complete Blood Count
Check blood routine indicators such as white blood cells, neutrophils, hemoglobin, and platelets.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Liver Function
Liver function tests such as Alanine aminotransferase and Aspartate aminotransferase.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Renal Function
Testing renal function such as serum creatinine, glomerular filtration rate, and blood urea nitrogen.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Serum Electrolytes
Testing blood electrolyte levels.
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Jan 2027; primary completion for Sep 2028, 20 months later.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 20 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Capecitabine