A Phase 2 interventional study of Retlirafusp alfa + nab-paclitaxel + apatinib and HEPIC in Gastric Cancer (Diagnosis), sponsored by Anhui Provincial Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Anhui Provincial Cancer Hospital · Phase 2, Interventional, and Treatment
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 32 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Anhui Provincial Cancer Hospital is the lead sponsor of 26 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma confirmed peritoneal , including positive cytology or tissue Advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after standard therapy Age ≥ 18 years; performance status score of 0 to 1; ≥ 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
Exclusion Criteria:
Gastric perforation or intestinal obstruction requiring gastrointestinal decompression; uncontrolled massive pleural effusion or ascites; or active bleeding History of to paclitaxel-class drugs Severe cardiovascular or cerebrovascular disease; severe hepatic or renal impairment; active infection; coagulation disorder; history of immunodeficiency or current 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Retlirafusp alfa + nab-paclitaxel + apatinib · Device: HEPIC
Drug pages: SHR-1701 · Albumin-Bound Paclitaxel · Apatinib
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.
In cycle 1, participants will receive HIPEC with intraperitoneal nab-paclitaxel , together with retlirafusp alfa.
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.
Time frame: 24months
Secondary Outcome
PFS, ORR, DoR, change in Peritoneal Cancer Index from baseline and safety
Time frame: 24 months
Exploratory biomarker analysis
iomarker samples will be collected at baseline and after completion of cycle 2 of treatment.
Time frame: Exploratory analysis of the change in biomarker level from baseline to the end of cycle 2
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
Of 293 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 76. This study's planned 37 months is below that.
Counting every sponsor, half of 358 studies reached it within 50 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: SHR-1701 · Albumin-Bound Paclitaxel · Apatinib
Anhui Provincial Cancer Hospital