Gastric Cancer (Diagnosis)Phase 2GCPM-HIPECNCT07904442
Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
A Phase 2 study testing Retlirafusp alfa + nab-paclitaxel + apatinib and HEPIC in people with Gastric Cancer (Diagnosis), run by Anhui Provincial Cancer Hospital.
Trial summary
This clinical study is designed to evaluate a combined treatment approach in adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread to the peritoneum (peritoneal metastasis), as confirmed by imaging, peritoneal fluid analysis, or laparoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (Diagnosis)
- What is being tested?
- Retlirafusp alfa + nab-paclitaxel + apatinib and HEPIC
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 28 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma Pathologically confirmed peritoneal metastasis, including positive cytology or tissue biopsy Advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after standard therapy Age ≥ 18 years; Eastern Cooperative Oncology Group performance status score of 0 to 1; life expectancy ≥ 3 months Adequate cardiac, hepatic, renal, and bone marrow function, with ability to tolerate systemic anticancer therapy Willingness to participate in the study and provide written informed consent
Who cannot join
- Gastric perforation or intestinal obstruction requiring gastrointestinal decompression; uncontrolled massive pleural effusion or ascites; or active bleeding History of hypersensitivity to paclitaxel-class drugs Severe cardiovascular or cerebrovascular disease; severe hepatic or renal impairment; active infection; coagulation disorder; history of immunodeficiency or current immunosuppressive therapy; uncontrolled epilepsy or central nervous system disease Pregnancy or lactation; any severe comorbidity or psychiatric disorder that, in the investigator's judgment, makes the participant unsuitable for study participation
About this study
This clinical study is designed to evaluate a combined treatment approach in adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread to the peritoneum (peritoneal metastasis), as confirmed by imaging, peritoneal fluid analysis, or laparoscopy. The study population also includes patients with malignant ascites. These patients have experienced disease progression despite receiving standard therapy. Management of this condition is particularly challenging because systemically administered chemotherapeutic agents achieve limited concentrations at peritoneal tumor sites, resulting in suboptimal disease control.
In this study, participants will receive a multi-modal treatment regimen consisting of the following components administered concurrently: (1) heated intraperitoneal chemotherapy (HIPEC) using nab-paclitaxel (albumin-bound paclitaxel), delivered directly into the abdominal cavity via a device that maintains the perfusate temperature at 42-43°C; (2) retlirafusp alfa, a PD-L1/TGF-βRII bispecific antibody fusion protein that simultaneously blocks two signaling pathways involved in tumor proliferation and angiogenesis; (3) intravenous nab-paclitaxel; and (4) apatinib, an oral small-molecule VEGFR-2 inhibitor that suppresses tumor-driven angiogenesis. The hyperthermia is expected to enhance the cytotoxic efficacy of intraperitoneal chemotherapy against peritoneal tumor deposits, while the bispecific antibody and apatinib are intended to control extra-peritoneal disease.
The primary objective of this study is to assess the safety and efficacy of this combined regimen, with a focus on disease control and overall survival. Participants will first complete an induction treatment phase, followed by repeated treatment cycles administered approximately every three weeks, and then proceed to maintenance therapy with retlirafusp alfa alone for up to two years. Throughout the study, participants will undergo regular imaging scans, laboratory tests, and clinical evaluations to monitor tumor response, treatment-related adverse events, and quality of life. This is a single-center study conducted in China.
- Conditions
- Gastric Cancer (Diagnosis)
- Being tested
- Retlirafusp alfa + nab-paclitaxel + apatinib, HEPIC
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retlirafusp alfa + nab-paclitaxel + apatinibDrug
Participants in this arm will receive retlirafusp alfa, nab-paclitaxel, apatinib, and heated intraperitoneal chemotherapy (HIPEC). Retlirafusp alfa is a PD-L1/TGF-βRII bispecific antibody fusion protein. Nab-paclitaxel will be used both for intravenous administration and for intraperitoneal administration during HIPEC. Apatinib is an oral small-molecule VEGFR-2 inhibitor. In cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel , together with retlirafusp alfa. They will also receive apatinib combined with retlirafusp alfa and intravenous nab-paclitaxel every 3 weeks from the second to eighth cycle. After completion of the 8-cycle combination phase, participants will receive maintenance treatment with retlirafusp alfa alone for up to 2 years, or until disease progression, unacceptable toxicity, death, or withdrawal from the study.
HEPICDevice
In cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel , together with retlirafusp alfa.
| Study group | Role | What they receive |
|---|---|---|
| Retlirafusp alfa + nab-paclitaxel + apatinib + HIPEC Arm | Experimental | Participants in this arm will receive retlirafusp alfa, nab-paclitaxel, apatinib, and heated intraperitoneal chemotherapy (HIPEC). Retlirafusp alfa is a PD-L1/TGF-βRII bispecific antibody fusion protein. Nab-paclitaxel will be used both for intravenous administration and for intraperitoneal administration during HIPEC. Apatinib is an oral small-molecule VEGFR-2 inhibitor.
In cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel, together with retlirafusp alfa. They will also receive apatinib combined with retlirafusp alfa and intravenous nab-paclitaxel from the second cycle to the eighth cycle. After completion of the 8-cycle combination phase, participants will receive maintenance treatment with retlirafusp alfa alone for up to 2 years, or until disease progression, unacceptable toxicity, death, or withdrawal from the study. Receives: Drug: Retlirafusp alfa + nab-paclitaxel + apatinib; Device: HEPIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year OS rate
The proportion of patients alive at 1 year after enrollment, calculated from the date of treatment initiation to the date of death from any cause. Patients who are still alive at 1 year will be censored.
Measured: 24months
Secondary outcomes (2)
Secondary Outcome
PFS, ORR, DoR, change in Peritoneal Cancer Index from baseline and safety
Measured: 24 months
Exploratory biomarker analysis
iomarker samples will be collected at baseline and after completion of cycle 2 of treatment.
Measured: Exploratory analysis of the change in biomarker level from baseline to the end of cycle 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Diagnosis)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xiaojing, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904442
- Sponsor's protocol ID
- XJS-2026-3-7(NK)
- Acronym
- GCPM-HIPEC
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT07904442
- Acronym / sponsor ID
- GCPM-HIPEC / XJS-2026-3-7(NK)
- Conditions
- Gastric Cancer (Diagnosis)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 29 Oct 2026 (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.
This clinical study is designed to evaluate a combined treatment approach in adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread to the peritoneum (peritoneal metastasis), as confirmed by imaging, peritoneal fluid analysis, or laparoscopy. The study population also includes patients with malignant ascites. These patients have experienced disease progression despite receiving standard therapy. Management of this condition is particularly challenging because systemically administered chemotherapeutic agents achieve limited concentrations at peritoneal tumor sites, resulting in suboptimal disease control.
In this study, participants will receive a multi-modal treatment regimen consisting of the following components administered concurrently: (1) heated intraperitoneal chemotherapy (HIPEC) using nab-paclitaxel (albumin-bound paclitaxel), delivered directly into the abdominal cavity via a device that maintains the perfusate temperature at 42-43°C; (2) retlirafusp alfa, a PD-L1/TGF-βRII bispecific antibody fusion protein that simultaneously blocks two signaling pathways involved in tumor proliferation and angiogenesis; (3) intravenous nab-paclitaxel; and (4) apatinib, an oral small-molecule VEGFR-2 inhibitor that suppresses tumor-driven angiogenesis. The hyperthermia is expected to enhance the cytotoxic efficacy of intraperitoneal chemotherapy against peritoneal tumor deposits, while the bispecific antibody and apatinib are intended to control extra-peritoneal disease.
The primary objective of this study is to assess the safety and efficacy of this combined regimen, with a focus on disease control and overall survival. Participants will first complete an induction treatment phase, followed by repeated treatment cycles administered approximately every three weeks, and then proceed to maintenance therapy with retlirafusp alfa alone for up to two years. Throughout the study, participants will undergo regular imaging scans, laboratory tests, and clinical evaluations to monitor tumor response, treatment-related adverse events, and quality of life. This is a single-center study conducted in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retlirafusp alfa + nab-paclitaxel + apatinib + HIPEC Arm | Experimental | Drug: Retlirafusp alfa + nab-paclitaxel + apatinib, Device: HEPICParticipants in this arm will receive retlirafusp alfa, nab-paclitaxel, apatinib, and heated intraperitoneal chemotherapy (HIPEC). Retlirafusp alfa is a PD-L1/TGF-βRII bispecific antibody fusion protein. Nab-paclitaxel will be used both for intravenous administration and for intraperitoneal administration during HIPEC. Apatinib is an oral small-molecule VEGFR-2 inhibitor. In cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel, together with retlirafusp alfa. They will also receive apatinib combined with retlirafusp alfa and intravenous nab-paclitaxel from the second cycle to the eighth cycle. After completion of the 8-cycle combination phase, participants will receive maintenance treatment with retlirafusp alfa alone for up to 2 years, or until disease progression, unacceptable toxicity, death, or withdrawal from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma Pathologically confirmed peritoneal metastasis, including positive cytology or tissue biopsy Advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after standard therapy Age ≥ 18 years; Eastern Cooperative Oncology Group performance status score of 0 to 1; life expectancy ≥ 3 months Adequate cardiac, hepatic, renal, and bone marrow function, with ability to tolerate systemic anticancer therapy Willingness to participate in the study and provide written informed consent
Key exclusion criteria (1 listed)
- Gastric perforation or intestinal obstruction requiring gastrointestinal decompression; uncontrolled massive pleural effusion or ascites; or active bleeding History of hypersensitivity to paclitaxel-class drugs Severe cardiovascular or cerebrovascular disease; severe hepatic or renal impairment; active infection; coagulation disorder; history of immunodeficiency or current immunosuppressive therapy; uncontrolled epilepsy or central nervous system disease Pregnancy or lactation; any severe comorbidity or psychiatric disorder that, in the investigator's judgment, makes the participant unsuitable for study participation
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 |
|---|---|---|
| Retlirafusp alfa + nab-paclitaxel + apatinibParticipants in this arm will receive retlirafusp alfa, nab-paclitaxel, apatinib, and heated intraperitoneal chemotherapy (HIPEC). Retlirafusp alfa is a PD-L1/TGF-βRII bispecific antibody fusion protein. Nab-paclitaxel will be used both for intravenous administration and for intraperitoneal administration during HIPEC. Apatinib is an oral small-molecule VEGFR-2 inhibitor. In cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel , together with retlirafusp alfa. They will also receive apatinib combined with retlirafusp alfa and intravenous nab-paclitaxel every 3 weeks from the second to eighth cycle. After completion of the 8-cycle combination phase, participants will receive maintenance treatment with retlirafusp alfa alone for up to 2 years, or until disease progression, unacceptable toxicity, death, or withdrawal from the study. | Drug | Retlirafusp alfa + nab-paclitaxel + apatinib + HIPEC Arm |
| HEPICIn cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel , together with retlirafusp alfa. | Device | Retlirafusp alfa + nab-paclitaxel + apatinib + HIPEC Arm |
Primary outcome
1-year OS rate
Time frame: 24months
The proportion of patients alive at 1 year after enrollment, calculated from the date of treatment initiation to the date of death from any cause. Patients who are still alive at 1 year will be censored.
2 secondary outcomes
Secondary Outcome
Time frame: 24 months
Exploratory biomarker analysis
Time frame: Exploratory analysis of the change in biomarker level from baseline to the end of cycle 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Retlirafusp alfa + nab-paclitaxel + apatinib and HEPIC in people with Gastric Cancer (Diagnosis), run by Anhui Provincial Cancer Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year OS rate (time frame: 24months). 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 29 Oct 2026.