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Clinical efficacy of sumatriptan combined with chemotherapy in the treatment of advanced colorectal cancer and its impact on the quality of patient survival Clinical research protocols

Clinical efficacy of sumatriptan combined with chemotherapy in the treatment of advanced colorectal cancer and its impact on the quality of patient survival Clinical research protocols

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083722
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

colorectal cancer

Interventions

Test Group:Sumatriptan + conventional chemotherapy regimens (including oxaliplatin, irinotecan and cisplatin)
control group: conventional chemotherapy regimens (including oxaliplatin, irinotecan and cisplatin)

Sponsors

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed colorectal adenocarcinoma with progression and/or recurrence in all patients after at least second-line systemic therapy; (2) Patients with definitively inoperable metastatic colorectal adenocarcinoma who have received prior second-line standard chemotherapy (fluorouracil-based, irinotecan, and oxaliplatin must have been used in the standard chemotherapy regimen) and have failed treatment; (3) Sumatriptan may be a third- or fourth-line regimen; (4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2; (5) Normal organ function: a. Haemoglobin =110 g/L b. Absolute neutrophil count = 1.5 × 109 / L c. Platelet count = 100 × 109 / L d. Total serum bilirubin = 6.0mmol/L e. AST and ALT = 3 times the upper limit of normal value, because the abnormal liver function is caused by underlying liver metastases, AST and ALT = 5 times the upper limit of normal value f. Serum creatinine acid = 133 µmol/L (6) Not participating in other clinical studies

Exclusion criteria

Exclusion criteria: (1) Ischaemic heart disease, ischaemic cerebrovascular disease and ischaemic peripheral vascular disease; (2) Severe hepatic impairment; (3) Patients with uncontrolled hypertension; (4) Those with poor compliance or who are participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
ORR;CA199;Eastern Cooperative Oncology Group Performance Status;LncRNA MALAT1;miR-194-5p;Karnofsky;safety;

Secondary

MeasureTime frame
DCR;CEA;

Countries

China

Contacts

Public ContactXing Cui

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

cdz45@163.com+86 135 8904 5327

Outcome results

None listed

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