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A clinical study on the efficacy and safety of warming Yang and dredging intestines method in the maintenance phase of metastatic colorectal cancer

Clinical study and mechanism exploration of the efficacy and safety of the Wenyang Tongxia method in the maintenance stage of metastatic colorectal cancer treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000229
Enrollment
Unknown
Registered
2024-08-13
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

colorectal cancer

Interventions

treatment group:Wenyang Tongxia formula

Sponsors

Xi yuan Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) patients aged 18-80, gender not limited, (2) pathologically diagnosed with colorectal cancer with clinical stage IV, (3) those who intended to receive maintenance therapy after criteria according to NCCN or CSCO colorectal cancer guidelines, (4) those with Eastern Cooperative Oncology Group (ECOG) score of 0-2, (5) those with expected survival =3 months, (6)those with measurable lesions according to RECIST 1.1 criteria, (7)those with no severe cardiac, pulmonary, hepatic, or renal function abnormalities, (8) those with normal coagulation function, no active bleeding or thrombotic disorders, (9) those who voluntary participation in the study, signed informed consent, (10) those who expected good compliance, able to follow-up on efficacy and adverse reactions as required by the protocol.

Exclusion criteria

Exclusion criteria: (1) patients with clinical symptoms of brain metastases, (2)those with other untreated malignancies, (3)those with dMMR for immunohistochemistry or MSI-H for genetic testing, (4) those with uncontrollable hypertension, (5) those with uncontrollable clinical cardiac symptoms or disease, (6) those with multiple factors that affect the absorption of oral medications, such as inability to swallow and intestinal obstruction (7)those at risk of bleeding, including the following: a. active peptic ulcer lesions; b. history of black stools and vomiting of blood within 3 months; c. hemoptysis within 1 month before study entry; (8) those who have major surgery, open biopsy, or significant trauma within 28 days before enrollment, (9) those who will be, or are, participating in other clinical trials (10) those who with other conditions such as pregnancy that researchers consider unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
maintenance progression free survival;

Secondary

MeasureTime frame
disease control rate;

Countries

China

Contacts

Public ContactZhang Tong

Xi yuan Hospital of CACMS

ashtray7654@126.com18710047520

Outcome results

None listed

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