Gastric CancerPhase 2/3NCT05300945
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
A Phase 2/3 study testing HIPEC in people with Gastric Cancer and Peritoneal Metastases, run by Zhixin Cao.
Trial summary
Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Peritoneal Metastases
- What is being tested?
- HIPEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2028
- Phase
- Phase 2/3
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
- histologically proven adenocarcinoma of stomach
- stage cT3-4N+M0
- no involvement of esophagus > 3 cm
- ECOG (Eastern Cooperative Oncology Group) : 0~1
- no previous chemotherapy or radiotherapy for any malignancy
- no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection
- Signed the Informed Consent Form
Who cannot join
- Serious diseases that are difficult to control
- Severe hepatic and renal dysfunction
- Abnormal coagulation
- The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
About this study
Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.
- Conditions
- Gastric Cancer, Peritoneal Metastases
- Being tested
- HIPEC
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECCombination product
HIPEC after gastrectomy with D2 local lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| HIPEC | Experimental | Not described Receives: Combination Product: HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal recurrence
Measured: 3 years
OS
overall survival
Measured: 3 years
Secondary outcomes (2)
DFS
disease free survival
Measured: 3 years
Adverse Events
Number and degree of Adverse Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhixin Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhixin Cao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300945
- Sponsor's protocol ID
- TJ_HIPEC-01
- Status last verified
- Dec 2022
- First submitted
- 20 Mar 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.