Advanced Colorectal CancerHYD-Cape-CRCNCT07913516
Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer
A study testing Capecitabine and Huangqi Yangyuan Formula (Chinese Herbal Decoction) in people with Advanced Colorectal Cancer and Capecitabine-Related Adverse Reaction, run by Huanfang Fan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Colorectal Cancer, Capecitabine-Related Adverse Reaction
- What is being tested?
- Capecitabine and Huangqi Yangyuan Formula (Chinese Herbal Decoction)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18-80 years.
- 2. Histologically confirmed stage IIIB-IV colorectal adenocarcinoma.
- 3. Eligible for planned or ongoing capecitabine monotherapy.
- 4. Expected survival ≥ 6 months.
- 5. ECOG performance status 0-2.
- 6. Baseline bone marrow, hepatic, and renal function adequate for chemotherapy.
- 7. Able to comply with oral medication, scheduled visits, and quality-of-life assessments.
- 8. Willing to provide written informed consent.
Who cannot join
- 1. Pregnant or breastfeeding women;
- 2. History of other systemic malignancies or gastrointestinal in situ cancer within the past 5 years;
- 3. Presence of severe underlying organic diseases affecting the heart, liver, kidneys, respiratory system, or hematopoietic system;
- 4. Persistent severe diarrhea, hand-foot ulcers, or severe malnutrition at baseline that precludes tolerance of chemotherapy;
- 5. Consciousness disorders or psychiatric conditions preventing independent completion of scale assessments and follow-up;
- 6. Known allergy to any ingredient in Huangqi Yangyuan Formula or capecitabine;
Show all 10Show fewer
- 7. Regular use of anti-tumor Chinese patent medicines, traditional Chinese herbal decoctions, long-term acupuncture/moxibustion for cancer treatment, or anti-cancer dietary supplements within the 2 weeks prior to enrollment, making washout period unfeasible;
- 8. Receipt of radiation therapy, other chemotherapy drugs, targeted therapy, or immunotherapy within the month prior to enrollment;
- 9. Patients currently undergoing double-agent chemotherapy or immunotherapy;
- 10. Refusal to discontinue other anti-cancer traditional Chinese medicine interventions or inability to truthfully report concomitant medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei Provincial, 050011
Huanfang Fan MD, +8615533959031, fhf701024@163.com
About this study
Official title: A Prospective Single-Arm Feasibility Clinical Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Patients With Advanced Colorectal Cancer
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.
Read the detailed description
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.
- Being tested
- Capecitabine, Huangqi Yangyuan Formula (Chinese Herbal Decoction)
- Keywords
- colorectal cancer, capecitabine, Chinese herbal medicine, Huangqi Yangyuan Formul, chemotherapy toxicity, feasibility study
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
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.
Huangqi Yangyuan Formula (Chinese Herbal Decoction)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Capecitabine plus Huangqi Yangyuan Formula | Experimental | 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). Receives: Drug: Capecitabine; Other: Huangqi Yangyuan Formula (Chinese Herbal Decoction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Serum Electrolytes
Testing blood electrolyte levels.
Measured: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label single-arm study. All enrolled participants receive the same intervention: capecitabine chemotherapy combined with Huangqi Yangyuan Formula. No concurrent control group is set. Published historical data of capecitabine monotherapy will be used as external reference for comparison.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huanfang Fan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Huanfang Fan, Hebei Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913516
- Sponsor's protocol ID
- HBZY2026-KYLL-029-01
- Acronym
- HYD-Cape-CRC
- Status last verified
- Nov 2026
- First submitted
- 21 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JJ, Kim TM, Yu SJ, Kim DW, Joh YH, Oh DY, Kwon JH, Kim TY, Heo DS, Bang YJ, Kim NK. Single-agent capecitabine in patients with metastatic colorectal cancer refractory to 5-fluorouracil/leucovorin chemotherapy. Jpn J Clin Oncol. 2004 Jul;34(7):400-4. doi: 10.1093/jjco/hyh068.
PubMed 15342667Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kroning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schuller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005 Jun 30;352(26):2696-704. doi: 10.1056/NEJMoa043116.
PubMed 15987918Zheng XY. Guiding Principles for Clinical Research of New Chinese Medicines (Trial). China Medical Science and Technology Press; 2002.
Zhong X, Chen J, Zhang Y, Hu H, Weng S, Zhang S, Yuan Y. Updates of CSCO guidelines for colorectal cancer version 2026. Chin J Cancer Res. 2026 Jun 30;38(3):329-335. doi: 10.21147/j.issn.1000-9604.2026.03.10. No abstract available.
PubMed 42421899Chinese Society of Clinical Oncology. CSCO Clinical Guidelines for Colorectal Cancer (2026 edition). People's Medical Publishing House; 2026.
Wang F, Chen G, Zhang Z, Yuan Y, Wang Y, Gao YH, Sheng W, Wang Z, Li X, Yuan X, Cai S, Ren L, Liu Y, Xu J, Zhang Y, Liang H, Wang X, Zhou A, Ying J, Li G, Cai M, Ji G, Li T, Wang J, Hu H, Nan K, Wang L, Zhang S, Li J, Xu RH. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of colorectal cancer, 2024 update. Cancer Commun (Lond). 2025 Mar;45(3):332-379. doi: 10.1002/cac2.12639. Epub 2024 Dec 31.
PubMed 39739441
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Feasibility Clinical Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07913516
- Acronym / sponsor ID
- HYD-Cape-CRC / HBZY2026-KYLL-029-01
- Keywords
- colorectal cancer, capecitabine, Chinese herbal medicine, Huangqi Yangyuan Formul, chemotherapy toxicity, feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Huanfang FanOther government
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label single-arm study. All enrolled participants receive the same intervention: capecitabine chemotherapy combined with Huangqi Yangyuan Formula. No concurrent control group is set. Published historical data of capecitabine monotherapy will be used as external reference for comparison.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Capecitabine plus Huangqi Yangyuan Formula | Experimental | Drug: Capecitabine, Other: Huangqi Yangyuan Formula (Chinese Herbal Decoction)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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Aged 18-80 years.
- 2. Histologically confirmed stage IIIB-IV colorectal adenocarcinoma.
- 3. Eligible for planned or ongoing capecitabine monotherapy.
- 4. Expected survival ≥ 6 months.
- 5. ECOG performance status 0-2.
Key exclusion criteria (10 listed)
- 1. Pregnant or breastfeeding women;
- 2. History of other systemic malignancies or gastrointestinal in situ cancer within the past 5 years;
- 3. Presence of severe underlying organic diseases affecting the heart, liver, kidneys, respiratory system, or hematopoietic system;
- 4. Persistent severe diarrhea, hand-foot ulcers, or severe malnutrition at baseline that precludes tolerance of chemotherapy;
- 5. Consciousness disorders or psychiatric conditions preventing independent completion of scale assessments and follow-up;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineOral 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. | Drug | Experimental: Capecitabine plus Huangqi Yangyuan Formula |
| 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. | Other | Experimental: Capecitabine plus Huangqi Yangyuan Formula |
Primary outcome
Completion Rate of Standardized Capecitabine Chemotherapy
Time frame: At the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Proportion of participants completing 4 cycles and 8 cycles of capecitabine chemotherapy without treatment discontinuation or major dose reduction.
9 secondary outcomes
Incidence and Grade of Chemotherapy-Related Adverse Events
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)
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Traditional Chinese Medicine Constitution Score
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Disease-Free Survival Rate
Time frame: At the end of the third month after the completion of chemotherapy.
Peripheral Blood T-Lymphocyte Subsets
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Complete Blood Count
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Liver Function
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Renal Function
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Serum Electrolytes
Time frame: At baseline, the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Results publication: PubMed 15342667Lee JJ, Kim TM, Yu SJ, Kim DW, Joh YH, Oh DY, Kwon JH, Kim TY, Heo DS, Bang YJ, Kim NK. Single-agent capecitabine in patients with metastatic colorectal cancer refractory to 5-fluorouracil/leucovorin chemotherapy. Jpn J Clin Oncol. 2004 Jul;34(7):400-4. doi: 10.1093/jjco/hyh068.
- Results publication: PubMed 15987918Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kroning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schuller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005 Jun 30;352(26):2696-704. doi: 10.1056/NEJMoa043116.
- Results publicationZheng XY. Guiding Principles for Clinical Research of New Chinese Medicines (Trial). China Medical Science and Technology Press; 2002.
- Results publication: PubMed 42421899Zhong X, Chen J, Zhang Y, Hu H, Weng S, Zhang S, Yuan Y. Updates of CSCO guidelines for colorectal cancer version 2026. Chin J Cancer Res. 2026 Jun 30;38(3):329-335. doi: 10.21147/j.issn.1000-9604.2026.03.10. No abstract available.
- Results publicationChinese Society of Clinical Oncology. CSCO Clinical Guidelines for Colorectal Cancer (2026 edition). People's Medical Publishing House; 2026.
- Results publication: PubMed 39739441Wang F, Chen G, Zhang Z, Yuan Y, Wang Y, Gao YH, Sheng W, Wang Z, Li X, Yuan X, Cai S, Ren L, Liu Y, Xu J, Zhang Y, Liang H, Wang X, Zhou A, Ying J, Li G, Cai M, Ji G, Li T, Wang J, Hu H, Nan K, Wang L, Zhang S, Li J, Xu RH. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of colorectal cancer, 2024 update. Cancer Commun (Lond). 2025 Mar;45(3):332-379. doi: 10.1002/cac2.12639. Epub 2024 Dec 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capecitabine and Huangqi Yangyuan Formula (Chinese Herbal Decoction) in people with Advanced Colorectal Cancer and Capecitabine-Related Adverse Reaction, run by Huanfang Fan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanfang Fan MD (+8615533959031, fhf701024@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of Standardized Capecitabine Chemotherapy (time frame: At the end of the fourth and eighth cycles of chemotherapy (each cycle is 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07913516, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.