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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04840264
Other study ID # ZhenJing
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 7, 2022
Est. completion date June 30, 2027

Study information

Verified date March 2024
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Jian Xiao, MD
Phone 86-20-38250745
Email xiao_jian@139.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.


Description:

The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 79
Est. completion date June 30, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 18-75 years of age; - ECOG PS =3; - pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma; - peritoneal carcinomatosis established by imaging data or pathological evidence; - MBO below the Treitz ligament based on clinical grounds or radiological findings; - considered as inoperable MBO by two independent surgical consultants; - Hb=60g/L, WBC =4×10E9/L, ANC=2×10E9/L,PLT=100×10E9/L; - Cr= Upper Normal Limit(UNL); - Tbil=1.5 UNL,AST=1.5 UNL, ALT=1.5 UNL, ALP=1.5 UNL; - Written informed consent form paticipants. Exclusion Criteria: - treated by a combination regimen containing all the study drugs; - allergy to any of the study drugs; - HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H); - strangulated intestinal obstruction; - active gastrointestinal bleeding; - uncontrolled active infection; - unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina); - severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc); - mental disorders that affect clinical treatment or central nervous system diseases; - concomitant cerebral parenchymal or meningeal metastasis; - HIV infection or untreated active hepatitis; - bowel surgery or stenting required due to obstruction; - pregnant or lactating women; - other conditions that are not suitable for participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Docetaxel
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Oxaliplatin
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
Fluorouracil
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.

Locations

Country Name City State
China The Sixth Affiliated hosipital, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4. — View Citation

Madariaga A, Lau J, Ghoshal A, Dzierzanowski T, Larkin P, Sobocki J, Dickman A, Furness K, Fazelzad R, Crawford GB, Lheureux S. MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer. Support Care Cancer. 2022 Jun;30(6):4711-4728. doi: 10.1007/s00520-022-06889-8. Epub 2022 Mar 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 60-day Obstruction Clearance Rate proportion of participants who achieved obstruction clearance within 60 days from start of treatment 60 days
Secondary 30-day Obstruction Clearance Rate proportion of participants who achieved obstruction clearance within 30 days from start of treatment 30 days
Secondary Time to Obstruction Clearance interval from start of treatment to obstruction clearance 60 days
Secondary Obstruction Clearance Duration interval from obstruction clearance to the next malignant bowel obstruction 2 years
Secondary Safety in terms of Adverse Events according to Common Terminology Criteria for Adverse Events version 5.0 2 years
Secondary Overall Survival interval from start of treatment to death or last follow-up 2 years
Secondary Quality of Life assessed by EORTC QLQ-OG25 in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25 3 months
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