Stage IV Gastric Cancer With MetastasisPhase 2NCT03604614
Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
A Phase 2 study testing Hyperthermic Intraperitoneal Chemotherapy and Without Hyperthermic Intraperitoneal Chemotherapy in people with Stage IV Gastric Cancer With Metastasis and Hyperthermic Intraperitoneal Chemotherapy, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stage IV Gastric Cancer With Metastasis, Hyperthermic Intraperitoneal Chemotherapy, Exploratory Behavior
- What is being tested?
- Hyperthermic Intraperitoneal Chemotherapy and Without Hyperthermic Intraperitoneal Chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 24 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy；
- Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis；
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1；
- American Society of Anesthesiologists （ASA） score: I to Ⅲ；
- Patient informed consent。
Who cannot join
- Pregnancy or female in suckling period；
- Severe mental illness；
- Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases；
- 5 years of history of other malignant diseases；
- A history of unstable angina or myocardial infarction within 6 months；
- History of cerebral infarction or cerebral hemorrhage within 6 months；
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- A history of sustained systemic corticosteroid treatment within 1 month；
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor；
- Pulmonary function test FEV1 <predicted value 50%。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120
Wei Wang, M.D.,PH.D., +86-13922255515, wangwei16400@163.com
Wenjun Xiong, M.D., +86-15920553177, xiongwj1988@163.com
About this study
Official title: A Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.
Read the detailed description
Gastric cancer is one of the most common digestive tumors in the world.In China, advanced gastric cancer with severe local progression or distant metastasis is more common.Gastric cancer with peritoneal carcinomatosis has an extremely poor prognosis,with a median survival of less than 6 months.Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is currently a treatment for malignant tumors in the abdominal cavity and prevents tumor recurrence and metastasis.Studies have shown that hyperthermic intraperitoneal perfusion chemotherapy (HIPEC) has good clinical efficacy in the prevention and treatment of peritoneal metastasis of gastric cancer and its associated malignant ascites.Therefore,we conduct a single-centre randomized controlled trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis. The metahnism of HIPEC is taking advantage of the difference in temperature sensitivity between cancer cells and normal cells. Perfusion of the abdominal cavity with a chemical fluid of the appropriate temperature can be performed. Suitable high temperatures can directly kill tumor cells.It is generally believed that the optimal temperature for the treatment of tumors is 42.5°C to 44°C.In this study,we set the temperature 43°C. Paclitaxel is a novel broad-spectrum antitumor drug,which has a unique anti-cancer mechanism.We use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs.The chemotherapy is SOX(Teggio and Oxaliplatin),.The primary endpoint is PFS. Secondary endpoints are one-year OS、canversion rate and ascites assessment. A phase III study PHOENIX-GC trial had finished enrollment,and the conclusion was the median OS 17.7 and 15.2 months respectively for IP and SP.The primary analysis did not show the statistical superiority of the IP regimen.The sensitivity analysis IP considering the imbalance of ascites, suggested clinical efficacy of IP PTX in gastric cancer with peritoneal metastasis. For this reason,we conduct a trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.
- Conditions
- Stage IV Gastric Cancer With Metastasis, Hyperthermic Intraperitoneal Chemotherapy, Exploratory Behavior
- Being tested
- Hyperthermic Intraperitoneal Chemotherapy, Without Hyperthermic Intraperitoneal Chemotherapy
- Keywords
- peritoneal metastatis, Hyperthermic Intraperitoneal Chemotherapy, Advanced gastric adenocarcinoma
- Medical subject headings
- Exploratory Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic Intraperitoneal ChemotherapyDrug
The investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs，75mg/m2 for the first time，50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.
Without Hyperthermic Intraperitoneal ChemotherapyDrug
The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC and chemotherapy | Experimental | Hyperthermic Intraperitoneal Chemotherapy and SOX（Tiggio+Oxaliplatin ） Receives: Drug: Hyperthermic Intraperitoneal Chemotherapy |
| Without HIPEC | Sham comparator | Without Hyperthermic Intraperitoneal Chemotherapy，Only SOX（Tiggio+Oxaliplatin ） Receives: Drug: Without Hyperthermic Intraperitoneal Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months
Secondary outcomes (3)
1-year survival
1-year overall survival rate
Measured: one year
Ascites assessment
Ascites assessment during surgery
Measured: Intraoperative
Median survival
Median Survival Time
Measured: From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Jun 2017
- Primary completion24 Aug 2017
- Study completion24 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Gastric Cancer With MetastasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Wei Wang, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese MedicineWenjun Xiong, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604614
- Sponsor's protocol ID
- GDPHCM-GI-03
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data has not been published.
Publications
Luo L, Zhang Z, Zeng H, Xu Y, Peng Y, Huang H, Lin Z, Xiong W, Wang W. Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial. J Gastrointest Oncol. 2025 Feb 28;16(1):17-26. doi: 10.21037/jgo-24-807. Epub 2025 Jan 9.
PubMed 40115934
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
- ClinicalTrials.gov ID
- NCT03604614
- Acronym / sponsor ID
- GDPHCM-GI-03
- Conditions
- Stage IV Gastric Cancer With Metastasis, Hyperthermic Intraperitoneal Chemotherapy, Exploratory Behavior
- Keywords
- peritoneal metastatis, Hyperthermic Intraperitoneal Chemotherapy, Advanced gastric adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2020 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.
Detailed description
Gastric cancer is one of the most common digestive tumors in the world.In China, advanced gastric cancer with severe local progression or distant metastasis is more common.Gastric cancer with peritoneal carcinomatosis has an extremely poor prognosis,with a median survival of less than 6 months.Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is currently a treatment for malignant tumors in the abdominal cavity and prevents tumor recurrence and metastasis.Studies have shown that hyperthermic intraperitoneal perfusion chemotherapy (HIPEC) has good clinical efficacy in the prevention and treatment of peritoneal metastasis of gastric cancer and its associated malignant ascites.Therefore,we conduct a single-centre randomized controlled trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis. The metahnism of HIPEC is taking advantage of the difference in temperature sensitivity between cancer cells and normal cells. Perfusion of the abdominal cavity with a chemical fluid of the appropriate temperature can be performed. Suitable high temperatures can directly kill tumor cells.It is generally believed that the optimal temperature for the treatment of tumors is 42.5°C to 44°C.In this study,we set the temperature 43°C. Paclitaxel is a novel broad-spectrum antitumor drug,which has a unique anti-cancer mechanism.We use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs.The chemotherapy is SOX(Teggio and Oxaliplatin),.The primary endpoint is PFS. Secondary endpoints are one-year OS、canversion rate and ascites assessment. A phase III study PHOENIX-GC trial had finished enrollment,and the conclusion was the median OS 17.7 and 15.2 months respectively for IP and SP.The primary analysis did not show the statistical superiority of the IP regimen.The sensitivity analysis IP considering the imbalance of ascites, suggested clinical efficacy of IP PTX in gastric cancer with peritoneal metastasis. For this reason,we conduct a trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIPEC and chemotherapy | Experimental | Drug: Hyperthermic Intraperitoneal ChemotherapyHyperthermic Intraperitoneal Chemotherapy and SOX（Tiggio+Oxaliplatin ） |
| Without HIPEC | Sham comparator | Drug: Without Hyperthermic Intraperitoneal ChemotherapyWithout Hyperthermic Intraperitoneal Chemotherapy，Only SOX（Tiggio+Oxaliplatin ） |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy；
- Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis；
- Eastern Cooperative Oncology Group (ECOG): 0 ot 1；
- American Society of Anesthesiologists （ASA） score: I to Ⅲ；
- Patient informed consent。
Key exclusion criteria (9 listed)
- Pregnancy or female in suckling period；
- Severe mental illness；
- Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases；
- 5 years of history of other malignant diseases；
- A history of unstable angina or myocardial infarction within 6 months；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermic Intraperitoneal ChemotherapyThe investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs，75mg/m2 for the first time，50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time. | Drug | HIPEC and chemotherapy |
| Without Hyperthermic Intraperitoneal ChemotherapyThe chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time. | Drug | Without HIPEC |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months
Progression-free survival
3 secondary outcomes
1-year survival
Time frame: one year
Ascites assessment
Time frame: Intraoperative
Median survival
Time frame: From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Derived from this study: PubMed 40115934Luo L, Zhang Z, Zeng H, Xu Y, Peng Y, Huang H, Lin Z, Xiong W, Wang W. Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial. J Gastrointest Oncol. 2025 Feb 28;16(1):17-26. doi: 10.21037/jgo-24-807. Epub 2025 Jan 9.
- Individual participant dataSharing planned: No. The data has not been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Wenjun Xiong principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperthermic Intraperitoneal Chemotherapy and Without Hyperthermic Intraperitoneal Chemotherapy in people with Stage IV Gastric Cancer With Metastasis and Hyperthermic Intraperitoneal Chemotherapy, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang, M.D., PH.D. (+86-13922255515, wangwei16400@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.