Stomach NeoplasmsPhase 2NCT05095467
HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction
A Phase 2 study testing HIPEC, Paclitaxel-albumin and Tegafur-gimeracil-oteracil potassium in people with Stomach Neoplasms and Peritoneal Metastases, run by Xuefei.Wang.
Trial summary
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms, Peritoneal Metastases
- What is being tested?
- HIPEC, Paclitaxel-albumin and Tegafur-gimeracil-oteracil potassium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old;
- The primary gastric lesion was diagnosed as gastric or esophagogastric junction adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma. )
- The tumor is located in the stomach or esophagogastric junction (Siewert type II/III)
- The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1*, P1 (*no other distant metastases except peritoneal metastasis)
- Good bone marrow reserve function: HB≥90g/L; ANC ≥1.5×10*9/L; PLT ≥80×10*9/L
- Good liver and kidney function reserve: BIL ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5×ULN; Crea≤1×ULN;
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- Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
- ECOG (Eastern Cooperative Oncology Group) physical status score 0-2;
- No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc;
- Written informed consent.
Who cannot join
- There are distant metastases other than peritoneal metastases;
- Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.;
- Suffer from other malignant tumors within five years;
- Body temperature ≥38℃ or complicated with infectious diseases requiring systemic treatment;
- If there is a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications;
- Clinically serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent history of myocardial infarction within 12 months;
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- Severe respiratory diseases;
- Severe liver and kidney dysfunction;
- Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs;
- Diseases such as severe diabetes, hyperthyroidism and hypothyroidism have not been clinically controlled.
- Those who continue to use glucocorticoid therapy within 1 month (except for local application) or who require immunosuppressive therapy for organ transplantation;
- Pregnant or lactating women;
- The patient has participated or is participating in other clinical studies (within 6 months);
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.
Read the detailed description
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include Patients With cT4aNxM0, P0, or cTxNxM1*, P1 Adenocarcinoma of the Stomach or Esophagogastric Junction, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period.
Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c.
Intervention:
Group A: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
Group B: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
Group C: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
In this study, the patient's overall survival was the main evaluation index. It is estimated that the case recruitment will be completed in 2 years, and the follow-up time will be 3 years. The total sample size is approximately 157 cases.
- Conditions
- Stomach Neoplasms, Peritoneal Metastases
- Being tested
- HIPEC, Paclitaxel-albumin, Tegafur-gimeracil-oteracil potassium, Surgery+HIPEC
- Keywords
- Stomach Neoplasms, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy, paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECProcedure or surgery
Also called Paclitaxel injection
The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.
Paclitaxel-albuminDrug
albumin paclitaxel D1, D8; S-1: D1-D14
Tegafur-gimeracil-oteracil potassiumDrug
40mg bid(BSA<1.5 m2) ，60mg bid(BSA>=1.5 m2); D1-D14, po, bid.
Surgery+HIPECProcedure or surgery
gastrectomy with D2 lymphadenectomy+HIPEC procedure
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | patients with locally resectable GC (cT4aNxM0, P0)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3) Receives: Procedure: HIPEC; Drug: Paclitaxel-albumin; Drug: Tegafur-gimeracil-oteracil potassium; Procedure: Surgery+HIPEC |
| Group B | Experimental | patients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3) Receives: Procedure: HIPEC; Drug: Paclitaxel-albumin; Drug: Tegafur-gimeracil-oteracil potassium; Procedure: Surgery+HIPEC |
| Group C | Experimental | group C is patients with peritoneal metastasis stage P1c (cTxNxM1, P1c)
1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3) Receives: Procedure: HIPEC; Drug: Paclitaxel-albumin; Drug: Tegafur-gimeracil-oteracil potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Overall Survival, OS
The time from the date of enrollment of the patient to the date of death or the date of the last follow-up
Measured: 3 years
Secondary outcomes (2)
3-year Progression Free Survival, PFS
The time from the date of enrollment of the patient to the first occurrence of disease progression or death from any cause.
Measured: 3 years
NCI CTC Adverse Events Version 4.0
Safety of HIPEC-AS plan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuefei.Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuefei.Wang, Shanghai Zhongshan Hospital
- Investigators
- Xuefei Wang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095467
- Sponsor's protocol ID
- B2021-574
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT05095467
- Acronym / sponsor ID
- B2021-574
- Conditions
- Stomach Neoplasms, Peritoneal Metastases
- Keywords
- Stomach Neoplasms, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy, paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Xuefei.WangUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Oct 2021 (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.
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.
Detailed description
HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include Patients With cT4aNxM0, P0, or cTxNxM1*, P1 Adenocarcinoma of the Stomach or Esophagogastric Junction, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period.
Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c.
Intervention:
Group A: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
Group B: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
Group C: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).
In this study, the patient's overall survival was the main evaluation index. It is estimated that the case recruitment will be completed in 2 years, and the follow-up time will be 3 years. The total sample size is approximately 157 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: HIPEC, Drug: Paclitaxel-albumin, Drug: Tegafur-gimeracil-oteracil potassium, Procedure: Surgery+HIPECpatients with locally resectable GC (cT4aNxM0, P0) 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3) |
| Group B | Experimental | Procedure: HIPEC, Drug: Paclitaxel-albumin, Drug: Tegafur-gimeracil-oteracil potassium, Procedure: Surgery+HIPECpatients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b) 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3) |
| Group C | Experimental | Procedure: HIPEC, Drug: Paclitaxel-albumin, Drug: Tegafur-gimeracil-oteracil potassiumgroup C is patients with peritoneal metastasis stage P1c (cTxNxM1, P1c) 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years old ≤ age ≤ 75 years old;
- The primary gastric lesion was diagnosed as gastric or esophagogastric junction adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma. )
- The tumor is located in the stomach or esophagogastric junction (Siewert type II/III)
- The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1*, P1 (*no other distant metastases except peritoneal metastasis)
- Good bone marrow reserve function: HB≥90g/L; ANC ≥1.5×10*9/L; PLT ≥80×10*9/L
Key exclusion criteria (13 listed)
- There are distant metastases other than peritoneal metastases;
- Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.;
- Suffer from other malignant tumors within five years;
- Body temperature ≥38℃ or complicated with infectious diseases requiring systemic treatment;
- If there is a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications;
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 |
|---|---|---|
| HIPECAlso: Paclitaxel injectionThe abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine. | Procedure or surgery | Group A, Group B, Group C |
| Paclitaxel-albuminalbumin paclitaxel D1, D8; S-1: D1-D14 | Drug | Group A, Group B, Group C |
| Tegafur-gimeracil-oteracil potassium40mg bid(BSA<1.5 m2) ，60mg bid(BSA>=1.5 m2); D1-D14, po, bid. | Drug | Group A, Group B, Group C |
| Surgery+HIPECgastrectomy with D2 lymphadenectomy+HIPEC procedure | Procedure or surgery | Group A, Group B |
Primary outcome
3-year Overall Survival, OS
Time frame: 3 years
The time from the date of enrollment of the patient to the date of death or the date of the last follow-up
2 secondary outcomes
3-year Progression Free Survival, PFS
Time frame: 3 years
NCI CTC Adverse Events Version 4.0
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Xuefei Wang, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HIPEC, Paclitaxel-albumin and Tegafur-gimeracil-oteracil potassium in people with Stomach Neoplasms and Peritoneal Metastases, run by Xuefei.Wang.
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 10 inclusion and 13 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 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Xuefei Wang, MD (+86 13917270428, wang.xuefei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Overall Survival, OS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2021.