Metastatic Gastric AdenocarcinomaPhase 2NCT04840264
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
A Phase 2 study testing Docetaxel, Oxaliplatin and Fluorouracil in people with Metastatic Gastric Adenocarcinoma and Metastatic Gastroesophageal Junction Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
- What is being tested?
- Docetaxel, Oxaliplatin and Fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2022to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510060
Jian Xiao, PhD, 13711114566, xiao_jian@139.com
About this study
Official title: A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction
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.
Read the detailed 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.
- Conditions
- Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
- Being tested
- Docetaxel, Oxaliplatin, Fluorouracil
- Keywords
- Malignant Bowel Obstruction, Docetaxel, Oxaliplatin, Fluorouracil
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
OxaliplatinDrug
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
FluorouracilDrug
Also called 5-FU
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A (First-Line Therapy) | Experimental | Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Fluorouracil |
| B (Second-Line Therapy) | Experimental | Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Fluorouracil |
| C (Third- or Later-Line Therapy) | Experimental | Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 60 days from start of treatment
Measured: 60 days
Secondary outcomes (6)
30-day Obstruction Clearance Rate
proportion of participants who achieved obstruction clearance within 30 days from start of treatment
Measured: 30 days
Time to Obstruction Clearance
interval from start of treatment to obstruction clearance
Measured: 60 days
Obstruction Clearance Duration
interval from obstruction clearance to the next malignant bowel obstruction
Measured: 2 years
Safety in terms of Adverse Events
according to Common Terminology Criteria for Adverse Events version 5.0
Measured: 2 years
Overall Survival
interval from start of treatment to death or last follow-up
Measured: 2 years
Quality of Life assessed by EORTC QLQ-OG25
in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Jian Xiao, Guangdong Provincial People's Hospital
- Investigators
- Jian Xiao, MD, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840264
- Sponsor's protocol ID
- ZhenJing
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17544243Madariaga 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.
PubMed 35274188