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Study on the dominant population of Quxie Capsule in different clinical pathways of metastatic colorectal cancer

Study on the dominant population of Quxie Capsule in different clinical pathways of metastatic colorectal cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005362
Enrollment
Unknown
Registered
2021-12-01
Start date
2021-12-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Maintenance treatment period + Quxie Capsule:Maintenance treatment + Quxie Capsule
Single drug chemotherapy or targeted therapy + Quxie Capsule:Single drug chemotherapy or targeted therapy + Quxie Capsule
Standard chemotherapy period + Quxie Capsule:Standard chemotherapy + Quxie Capsule
Simple TCM treatment period + Quxie Capsule:Simple TCM treatment + Quxie Capsule

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 18 years old, regardless of gender; 2. Colorectal cancer diagnosed by pathology; 3. The clinical stage is stage IV; 4. ECoG 0-2 points; 5. Estimated survival time = 3 months; 6. Measurable lesions meeting RECIST 1.1 standard; 7. Voluntarily join the study and sign the informed consent form; 8. Those with good compliance are expected to follow up the efficacy and adverse reactions according to the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Patients whose clinical stage is IVA stage and who have the opportunity of radical surgery or potential transformation; 2. Diarrhea > 3 times / day, or diarrhea of grade II or above (CTCAE v4.03 grade); 3. Complicated with severe cardiovascular system complications, cerebrovascular system complications, active hepatitis and severe liver and kidney dysfunction; 4. There are many factors affecting the absorption of oral drugs, such as inability to swallow and intestinal obstruction; 5. Any unstable situation or situation that may endanger the safety of patients and their compliance with the study, such as schizophrenia and other serious mental diseases; 6. Patients who will or are participating in other clinical trials;

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;Progression free survival;

Countries

China

Contacts

Public ContactYang-Yufei
yyf93@vip.sina.com010-62835678

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026