Colorectal CancerNCT07854405
A Clinical Study on the Synergistic Effects of Zhen-Qi-Jie-Du Granules in Palliative Care for Advanced Colorectal Cancer
A study testing Zhen-Qi-Jie-Du Granules II and Zhen-Qi-Jie-Du Granules I in people with Colorectal Cancer, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether Zhen-Qi-Jie-Du Granules combined with chemotherapy works to treat unresectable stage IV microsatellite-stable colorectal cancer in adults. It will also learn about the safety of Zhen-Qi-Jie-Du Granules when added to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Zhen-Qi-Jie-Du Granules II and Zhen-Qi-Jie-Du Granules I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,540 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 1 Oct 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
- Subjects meeting all of the following criteria will be eligible to participate in this study:
- Patients with colorectal cancer who have a confirmed pathological diagnosis meeting the diagnostic criteria for the disease; patients with stage IV (MSS) colorectal cancer who are not candidates for curative surgery or who have a confirmed recurrence or metastasis post-surgery and are therefore ineligible for surgical treatment; and patients with at least one measurable lesion assessable according to RECIST 1.1 criteria.
- Have not received prior systemic therapy for metastatic disease (enrolment in the first-line sub-arm); have failed prior first-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the second-line sub-arm); have failed prior second-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the third-line sub-arm).
- Traditional Chinese Medicine (TCM) diagnosis consistent with TCM criteria for colorectal cancer (deficiency of both spleen and kidney, with internal obstruction by stasis and toxins).
- Expected survival of 3 months or more.
- Able to swallow, retain and absorb oral medication
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- Aged 18-80 years; both men and women are eligible.
- ECOG performance status score of 0-1. Understand the details of this study, voluntarily agree to participate, and sign the informed consent form.
- Note: 1. For patients with early-stage disease (e.g. stages I-III) who have undergone surgery followed by chemotherapy (e.g. as part of adjuvant therapy), the emergence of new lesions or evidence of disease recurrence during treatment or within 6 months of its completion will be considered as receiving first-line treatment for metastatic disease.2. Patients who have previously received systemic neoadjuvant chemotherapy (including in combination with radiotherapy) and who develop new lesions or evidence of disease recurrence during treatment or within 6 months of its completion will be considered to be receiving first-line treatment for metastatic disease.
Who cannot join
- A subject is ineligible for the study if they meet any of the following criteria:
- A history of other malignancies within the past five years (excluding basal cell carcinoma or squamous cell carcinoma of the skin treated with curative therapy, prostatic intraepithelial neoplasia, cervical carcinoma in situ, Bowen's disease, or prostate cancer with a Gleason score ≤6).
- Concurrent severe organic diseases affecting the cardiovascular, cerebrovascular, autoimmune, musculoskeletal, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, urinary or endocrine systems; clinically significant ECG abnormalities as assessed by the investigator; or abnormal liver or kidney function. (Normal liver and kidney function criteria: a. Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL. If direct (conjugated) bilirubin is ≤ 1.5 times the upper limit of normal (ULN) and indirect (unconjugated) bilirubin is ≤ 4.25 times ULN, total bilirubin > 1.5 times ULN is permitted. b. ALT and AST ≤ 2.5 times ULN, or ≤ 5 times ULN in the presence of liver metastases.c. Estimated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula, or creatinine clearance determined via 24-hour urine collection, or according to the local institution's standard method.
- Impaired gastrointestinal function (e.g. uncontrolled nausea, vomiting or diarrhoea, malabsorption syndrome, small bowel resection) or conditions likely to significantly alter the absorption of the oral study intervention, or recent changes in bowel function suggestive of current or impending intestinal obstruction.
- Any unstable condition or condition that may jeopardise patient safety or compliance with the study, such as a desire to conceive, pregnancy, breastfeeding, or mental disorders including depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia.
- Individuals with an allergy to the components of this traditional Chinese medicine.
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- Patients receiving other treatments prior to enrolment that may affect the efficacy assessment of this trial.
- Patients who have recently participated in or are currently participating in clinical trials of other drugs.
- Any other circumstances deemed unsuitable for inclusion by the investigator.
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
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210000
About this study
The goal of this clinical trial is to learn whether Zhen-Qi-Jie-Du Granules combined with chemotherapy works to treat unresectable stage IV microsatellite-stable colorectal cancer in adults. It will also learn about the safety of Zhen-Qi-Jie-Du Granules when added to chemotherapy. The main questions it aims to answer are:
Does Zhen-Qi-Jie-Du Granules plus chemotherapy prolong progression-free survival compared with chemotherapy alone? Does Zhen-Qi-Jie-Du Granules improve disease control rate, objective response rate, cancer-related fatigue, myelosuppression, quality of life and traditional Chinese medicine syndrome for participants receiving chemotherapy? What medical problems and side effects do participants experience when taking Zhen-Qi-Jie-Du Granules alongside chemotherapy? Researchers will compare chemotherapy plus Zhen-Qi-Jie-Du Granules (intervention group) versus chemotherapy alone (control group). Participants may enter either a randomized controlled trial cohort or an observational cohort according to their own willingness.
Read more
Participants will:
Receive investigator-selected first-line, second-line or third-line standard chemotherapy regimens for advanced colorectal cancer Take Zhen-Qi-Jie-Du Granules (2 sachets, twice daily after breakfast and dinner) if assigned to the intervention group, for up to 6 months (or until treatment discontinuation criteria are met) Attend clinic visits for physical examination, vital signs, ECOG performance status assessment, laboratory blood and urine tests, chest and abdominal CT/MRI tumor imaging scans Complete validated questionnaires including FACIT-F, EORTC QLQ-C30, MDASI-TCM and the Late-Stage Colorectal Cancer TCM Syndrome Scale at scheduled visits Have adverse events, concomitant medications and survival status recorded throughout the study Provide plasma and stool biological samples at screening and scheduled follow-up visits Complete an End-of-Treatment (EOT) visit when stopping study treatment, regardless of the reason for discontinuation
- Conditions
- Colorectal Cancer
- Being tested
- Zhen-Qi-Jie-Du Granules II, Zhen-Qi-Jie-Du Granules I
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zhen-Qi-Jie-Du Granules IIDrug
take Zhen-Qi-Jie-Du Granules II with Chemotherapy: 2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.
Zhen-Qi-Jie-Du Granules IDrug
take Zhen-Qi-Jie-Du Granules I with Chemotherapy: 2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.
| Study group | Role | What they receive |
|---|---|---|
| RCT1 | Experimental | Treatment-naïve for metastatic colorectal cancer; randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location [left-sided / right-sided colon-rectum] and presence/absence of liver metastasis).
Chemotherapy: Investigator-selected first-line systemic chemotherapy for metastatic colorectal cancer.
For intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-Ⅰ：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.
For control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment.
Assessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window Receives: Drug: Zhen-Qi-Jie-Du Granules I |
| OBS-1 | Experimental | Population: First-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation.
Chemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT1 arms) Zhen-Qi-Jie-Du Granules Formula-Ⅰ: Whether to take is at the subject's own discretion. Receives: Drug: Zhen-Qi-Jie-Du Granules I |
| RCT2 | Experimental | randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location [left-sided / right-sided colon-rectum] and presence/absence of liver metastasis).
Chemotherapy: Investigator-selected second-line systemic chemotherapy for metastatic colorectal cancer.
For intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-II：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.
For control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment.
Assessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window Receives: Drug: Zhen-Qi-Jie-Du Granules II |
| OBS-2 | Experimental | Population: Second-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation.
Chemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT2 arms) Zhen-Qi-Jie-Du Granules Formula-II: Whether to take is at the subject's own discretion. Receives: Drug: Zhen-Qi-Jie-Du Granules II |
| RCT3 | Experimental | randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location [left-sided / right-sided colon-rectum] and presence/absence of liver metastasis).
Chemotherapy: Investigator-selected third-line systemic chemotherapy for metastatic colorectal cancer.
For intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-II：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.
For control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment.
Assessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window Receives: Drug: Zhen-Qi-Jie-Du Granules II |
| OBS-3 | Experimental | Population: Third-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation.
Chemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT3 arms) Zhen-Qi-Jie-Du Granules Formula-II: Whether to take is at the subject's own discretion. Receives: Drug: Zhen-Qi-Jie-Du Granules II |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
assessed by an Independent Review Committee (IRC) and using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
Measured: one year after enrollment
Secondary outcomes (7)
DCR
assessed by an Independent Review Committee (IRC)
Measured: 1 year
ORR
assessed by an Independent Review Committee (IRC)
Measured: 1 year
Degree of cancer-related fatigue
investigator-assessed using the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale. FACIT-F is a patient-reported outcome scale containing 13 items. Respondents answer each item based on their fatigue experience in the past 7 days with a 5-point Likert scale. Reverse scoring is applied to positively phrased items before total score calculation. The total score ranges from 0 (minimum) to 52 (maximum). Higher FACIT-F scores indicate less fatigue and better functional status, while lower scores indicate more severe fatigue. This scale is widely validated for chronic disease populations including cancer patients. It is used in clinical trials to quantitatively assess fatigue symptoms and functional impairment, and to evaluate changes in fatigue before and after intervention.
Measured: 1 year
Degree of myelosuppression
investigator-assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Measured: 1 year
Quality of life
investigator-assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) .EORTC QLQ-C30 is a patient-reported outcome questionnaire with 30 items, developed to assess health-related quality of life in cancer patients. It includes 5 functional scales, 3 symptom scales, single symptom items, and a global health status / quality of life scale. Subjects respond according to their condition during the past week. After standard scoring transformation, each scale score ranges from 0 (minimum) to 100 (maximum).For functional scales and the global health status scale: higher scores represent better function and higher quality of life. For symptom scales and single symptom items: higher scores indicate more severe symptoms.
Measured: 1 year
Traditional Chinese Medicine (TCM) syndromes
investigator-assessed - Survey Scale of TCM Syndromes in Advanced Colorectal Cancer
Measured: At each scheduled study visit until the end of the study at 12 months.
TCM symptom assessment
investigator-assessed using the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM).MDASI-TCM is a patient-reported outcome instrument, consisting of the core MDASI symptom items plus supplementary traditional Chinese medicine symptom items. Subjects rate the severity of each symptom over the past 24 hours using a 0-10 numeric rating scale, where 0 represents "not present" and 10 represents "as bad as you can imagine". The total composite score ranges from 0 (minimum) to 10 (maximum) for each symptom item. Higher scores mean more severe symptoms and greater symptom disturbance; lower scores indicate milder symptoms. This scale has been validated in cancer patients for combined western and TCM symptom assessment. It is applied in clinical trials to quantify symptom burden and evaluate the effect of interventions on symptom relief.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Collaborative Innovation Center for Traditional Chinese Medicine Cancer Prevention and Treatment
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854405
- Sponsor's protocol ID
- ZLXTCXZX-2025002
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Synergistic Effects of Zhen-Qi-Jie-Du Granules in Palliative Care for Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07854405
- Acronym / sponsor ID
- ZLXTCXZX-2025002
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,540 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Collaborative Innovation Center for Traditional Chinese Medicine Cancer Prevention and Treatment
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 2 Oct 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.
The goal of this clinical trial is to learn whether Zhen-Qi-Jie-Du Granules combined with chemotherapy works to treat unresectable stage IV microsatellite-stable colorectal cancer in adults. It will also learn about the safety of Zhen-Qi-Jie-Du Granules when added to chemotherapy. The main questions it aims to answer are:
Does Zhen-Qi-Jie-Du Granules plus chemotherapy prolong progression-free survival compared with chemotherapy alone? Does Zhen-Qi-Jie-Du Granules improve disease control rate, objective response rate, cancer-related fatigue, myelosuppression, quality of life and traditional Chinese medicine syndrome for participants receiving chemotherapy? What medical problems and side effects do participants experience when taking Zhen-Qi-Jie-Du Granules alongside chemotherapy? Researchers will compare chemotherapy plus Zhen-Qi-Jie-Du Granules (intervention group) versus chemotherapy alone (control group). Participants may enter either a randomized controlled trial cohort or an observational cohort according to their own willingness.
Participants will:
Receive investigator-selected first-line, second-line or third-line standard chemotherapy regimens for advanced colorectal cancer Take Zhen-Qi-Jie-Du Granules (2 sachets, twice daily after breakfast and dinner) if assigned to the intervention group, for up to 6 months (or until treatment discontinuation criteria are met) Attend clinic visits for physical examination, vital signs, ECOG performance status assessment, laboratory blood and urine tests, chest and abdominal CT/MRI tumor imaging scans Complete validated questionnaires including FACIT-F, EORTC QLQ-C30, MDASI-TCM and the Late-Stage Colorectal Cancer TCM Syndrome Scale at scheduled visits Have adverse events, concomitant medications and survival status recorded throughout the study Provide plasma and stool biological samples at screening and scheduled follow-up visits Complete an End-of-Treatment (EOT) visit when stopping study treatment, regardless of the reason for discontinuation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RCT1 | Experimental | Drug: Zhen-Qi-Jie-Du Granules ITreatment-naïve for metastatic colorectal cancer; randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location [left-sided / right-sided colon-rectum] and presence/absence of liver metastasis). Chemotherapy: Investigator-selected first-line systemic chemotherapy for metastatic colorectal cancer. For intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-Ⅰ：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria. For control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment. Assessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window |
| OBS-1 | Experimental | Drug: Zhen-Qi-Jie-Du Granules IPopulation: First-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation. Chemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT1 arms) Zhen-Qi-Jie-Du Granules Formula-Ⅰ: Whether to take is at the subject's own discretion. |
| RCT2 | Experimental | Drug: Zhen-Qi-Jie-Du Granules IIrandomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location [left-sided / right-sided colon-rectum] and presence/absence of liver metastasis). Chemotherapy: Investigator-selected second-line systemic chemotherapy for metastatic colorectal cancer. For intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-II：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria. For control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment. Assessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window |
| OBS-2 | Experimental | Drug: Zhen-Qi-Jie-Du Granules IIPopulation: Second-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation. Chemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT2 arms) Zhen-Qi-Jie-Du Granules Formula-II: Whether to take is at the subject's own discretion. |
| RCT3 | Experimental | Drug: Zhen-Qi-Jie-Du Granules IIrandomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location [left-sided / right-sided colon-rectum] and presence/absence of liver metastasis). Chemotherapy: Investigator-selected third-line systemic chemotherapy for metastatic colorectal cancer. For intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-II：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria. For control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment. Assessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window |
| OBS-3 | Experimental | Drug: Zhen-Qi-Jie-Du Granules IIPopulation: Third-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation. Chemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT3 arms) Zhen-Qi-Jie-Du Granules Formula-II: Whether to take is at the subject's own discretion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects meeting all of the following criteria will be eligible to participate in this study:
- Patients with colorectal cancer who have a confirmed pathological diagnosis meeting the diagnostic criteria for the disease; patients with stage IV (MSS) colorectal cancer who are not candidates for curative surgery or who have a confirmed recurrence or metastasis post-surgery and are therefore ineligible for surgical treatment; and patients with at least one measurable lesion assessable according to RECIST 1.1 criteria.
- Have not received prior systemic therapy for metastatic disease (enrolment in the first-line sub-arm); have failed prior first-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the second-line sub-arm); have failed prior second-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the third-line sub-arm).
- Traditional Chinese Medicine (TCM) diagnosis consistent with TCM criteria for colorectal cancer (deficiency of both spleen and kidney, with internal obstruction by stasis and toxins).
- Expected survival of 3 months or more.
Key exclusion criteria (9 listed)
- A history of other malignancies within the past five years (excluding basal cell carcinoma or squamous cell carcinoma of the skin treated with curative therapy, prostatic intraepithelial neoplasia, cervical carcinoma in situ, Bowen's disease, or prostate cancer with a Gleason score ≤6).
- Concurrent severe organic diseases affecting the cardiovascular, cerebrovascular, autoimmune, musculoskeletal, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, urinary or endocrine systems; clinically significant ECG abnormalities as assessed by the investigator; or abnormal liver or kidney function. (Normal liver and kidney function criteria: a. Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL. If direct (conjugated) bilirubin is ≤ 1.5 times the upper limit of normal (ULN) and indirect (unconjugated) bilirubin is ≤ 4.25 times ULN, total bilirubin > 1.5 times ULN is permitted. b. ALT and AST ≤ 2.5 times ULN, or ≤ 5 times ULN in the presence of liver metastases.c. Estimated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula, or creatinine clearance determined via 24-hour urine collection, or according to the local institution's standard method.
- Impaired gastrointestinal function (e.g. uncontrolled nausea, vomiting or diarrhoea, malabsorption syndrome, small bowel resection) or conditions likely to significantly alter the absorption of the oral study intervention, or recent changes in bowel function suggestive of current or impending intestinal obstruction.
- Any unstable condition or condition that may jeopardise patient safety or compliance with the study, such as a desire to conceive, pregnancy, breastfeeding, or mental disorders including depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia.
- Individuals with an allergy to the components of this traditional Chinese medicine.
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 |
|---|---|---|
| Zhen-Qi-Jie-Du Granules IItake Zhen-Qi-Jie-Du Granules II with Chemotherapy: 2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria. | Drug | OBS-2, OBS-3, RCT2, RCT3 |
| Zhen-Qi-Jie-Du Granules Itake Zhen-Qi-Jie-Du Granules I with Chemotherapy: 2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria. | Drug | OBS-1, RCT1 |
Primary outcome
PFS
Time frame: one year after enrollment
assessed by an Independent Review Committee (IRC) and using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
7 secondary outcomes
DCR
Time frame: 1 year
ORR
Time frame: 1 year
Degree of cancer-related fatigue
Time frame: 1 year
Degree of myelosuppression
Time frame: 1 year
Quality of life
Time frame: 1 year
Traditional Chinese Medicine (TCM) syndromes
Time frame: At each scheduled study visit until the end of the study at 12 months.
TCM symptom assessment
Time frame: 1 year
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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zhen-Qi-Jie-Du Granules II and Zhen-Qi-Jie-Du Granules I in people with Colorectal Cancer, run by Jiangsu Famous Medical Technology Co., Ltd. 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 9 inclusion and 9 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 2 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: one year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.