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The efficacy of Arepitant in salvage treatment of chemotherapy-induced nausea and vomiting associated with moderate chemotherapy regime for gastrointestinal cancer patients: A phase II clinical study

The efficacy of Arepitant in salvage treatment of chemotherapy-induced nausea and vomiting associated with moderate chemotherapy regime for gastrointestinal cancer patients: A phase II clinical study

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17012883
Enrollment
Unknown
Registered
2017-10-04
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-10-09

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

Conditions

gastric cancer, colorectal cancer, and pancreatic cancer

Interventions

1:the patients without acheiving complete response of CINV,combine with Arepitant when the second cycle chemotherapy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosed as gastric cancer, colorectal cancer, and pancreatic cancer by pathology; 2) more than 18 years old; 3) ECOG=1 score; 4) The anticipatory survival time=4 mouths; 5) The first time to chemotherapy, no any other anti-tumor therapy before enrollment, chemotherapy regimens include FOLFOX, Cape OX, SOX, FOLFIRI, FOLFOXIRI,FOLFIRINOX; 6) No radiotherapy or targeted therapy plan within two cycles chemotherapy; 7) No brain metastases and bone metastases with pain uncontrol; 8) No history of chronic digestive disease,chronic nausea and vomiting (such as the history of dizziness, meniere's syndrome); 9) The baseline blood and biochemical test meet the following criteria:neutrophil absolute count (ANC) =1.5×10^9/L; platelet =80 × 10^9/L, hemoglobin =80g/L; serum creatinine <1.5 times the normal upper limit; serum total bilirubin <2.5 times the normal upper limit;ALT,AST, ALP = 2.5 times the normal upper limit; if with the liver metastases,the value must less than 5 times the normal upper limit; 10) Childbearing age women without pregnancy, must take enough contraceptive measures during the reasearch; 11) volunteer to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Allergy to Arepitant and dexamethasone; 2) Had received other chemotherapy; 3) Had received other radiotherapy of the abdomen, the thorax and the pelvis; 4) uncontrolled carcinous pain or the gastrointestinal reaction of opioid medicine; 5) happened nausea or vomiting in the past three days; 6) during past 1 year with the history of active digestive tract ulcer and gastrointestinal bleeding; 7) cant read or fill out questionnaire survey independently; 8) cant take oral medicine; 9) With poor compliance, cant complete the reaserch followed the plan; 10) with a long term to use hormone (such as immune system diseases including systemic lupus erythematosus (sle) and adrenal cortex hypofunction, etc.; 11) with brain metastases; 12) pregnant or breastfeeding woman; 13) with other malignant tumors; 14) with radiotherapy during chemotharapy; 15) The reaserchers assess not conform to the study.

Design outcomes

Primary

MeasureTime frame
the response of chemotherapy-induced nausea and vomiting;

Countries

China

Contacts

Public ContactCao Dan

West China Hospital, Sichuan University

caodan316@163.com+86 18980605963

Outcome results

None listed

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