Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2NCT07902648
Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC in people with Gastric/Gastroesophageal Junction Adenocarcinoma and Oligometastatic Peritoneal Metastasis, run by Fujian Cancer Hospital.
Trial summary
This study is a prospective, multicenter, open-label, exploratory phase II clinical trial aimed at evaluating the efficacy and safety of serplulimab combined with DOS, lenvatinib, and PIPACS in patients with oligometastatic peritoneal metastases of gastric and gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric/Gastroesophageal Junction Adenocarcinoma, Oligometastatic Peritoneal Metastasis
- What is being tested?
- Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 31 Dec 2028
- 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
- Age >18 years on the day of signing the Informed Consent Form;
- The subject is able to comprehend the procedures and methods of this clinical study, and voluntarily signs the informed consent form after providing full informed consent.
- Gastric or gastroesophageal junction cancer (HER2-negative) confirmed by histology or cytology;
- Diagnosed via laparoscope as initially resectable gastric cancer/gastroesophageal junction cancer, accompanied by positive cytology in abdominal cavity washing solution, and/or low-burden peritoneal metastasis (peritoneal cancer index PCI ≤ 10);
- ECOG PS 0-2, expected survival ≥3 months;
- Organ function meets the following criteria (within 10 days of first receiving the Investigational Product);
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- Hematology: Platelet count ≥100×10⁹/L, hemoglobin ≥8g/dL, ANC ≥1.5×10⁹/L, and no blood products, erythropoiesis-stimulating agents, or colony-stimulating factors therapy received within the past 7 days;
- Renal function: Serum creatinine is within the normal upper limit range set by the institution;
- Liver function: Total bilirubin ≤ 1.5×UNL; if total bilirubin > 1.5×UNL, then direct bilirubin should be ≤ UNL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5×UNL, albumin > 2.5 mg/dL;
- Coagulation function: International normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT) ≤ 1.5×UNL; if the subject is undergoing anticoagulation therapy, it should be within the established therapeutic range;
- For women of childbearing potential, the serum pregnancy test within 72 hours prior to the first administration of the investigational product must be negative. If the urine test result is positive or cannot be confirmed as negative, further serum pregnancy testing is required.
- Women of childbearing age should agree to use two effective methods of birth control or undergo surgical sterilization, or choose to avoid any heterosexual intercourse throughout the study period and for 120 days after the last drug administration. (Women who have been postmenopausal for more than one year and have not undergone surgical sterilization are considered infertile.) Lactating women must cease breastfeeding.
- Male subjects should agree to adopt effective contraceptive measures from the first administration until 120 days after the final administration.
Who cannot join
- There is distant metastasis outside the peritoneum.
- Peritoneal cancer index (PCI) > 10;
- Siewert type I squamous cell carcinoma of the gastroesophageal junction, primarily involving the esophagus;
- Presence of active central nervous system metastasis or meningitis carcinomatosa;
- There is an uncontrolled abdominal infection, intestinal obstruction, grade 3 abdominal effusion, or a risk of gastrointestinal fistula or perforation;
- Diagnostic biopsy confirmed EB virus positive, microsatellite instability (MSI) positive, and human epidermal growth factor receptor 2 (HER2) positive.
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- Received systemic immunosuppressant therapy within 28 days prior to the study;
- Known to have an allergy to any investigational product or any excipient of the investigational product;
- Diagnosed with another malignancy within the past 5 years, and the tumor is currently in a progressive stage or requires treatment (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ that has undergone potentially curative treatment);
- There is active autoimmune disease, and systemic therapy (including the use of disease-modifying drugs, corticosteroids, or immunosuppressants) has been received in the past two years. Replacement therapy (e.g., thyroxine replacement for hypothyroidism, insulin therapy for diabetes mellitus, or physiological glucocorticoid supplementation for adrenal or pituitary insufficiency) is not considered systemic therapy.
- Previously suffered from (non-infectious) pneumonia requiring glucocorticoid therapy, or currently suffering from pneumonia;
- There is an active infection requiring systemic therapy.
- The presence of any history of disease, therapy, or laboratory abnormalities that may interfere with the test results, affect the subject's full participation, or be deemed unsuitable for the subject's participation in the study by the Sub investigator;
- Past or current mental disease or drug abuse, deemed by the Sub investigator as unable to comply with trial requirements;
- Already pregnant or in the lactation period, or plans to become pregnant or cause a woman to become pregnant during the trial period (from the start of pre-screening or screening visit to 120 days after the final administration);
- Known infection with Human Immunodeficiency Virus (HIV1/2 antibody positive);
- Presence of active hepatitis B (Hepatitis B Surface Antigen [HBsAg] positive and HBV DNA above 1000 copies/ml or 200 IU/ml) or hepatitis C (HCV antibody [HCVAb] positive and HCV RNA above the lower limit of detection at the study center);
- Received any live vaccine within 30 days prior to the first use of the investigational medicinal product.
About this study
Official title: Serplulimab, Docetaxel, Oxaliplatin, S1 and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma: A Single Arm Multicentre Clinical Trail
This study is a prospective, multicenter, open-label, exploratory phase II clinical trial aimed at evaluating the efficacy and safety of serplulimab combined with DOS, lenvatinib, and PIPACS in patients with oligometastatic peritoneal metastases of gastric and gastroesophageal junction adenocarcinoma. A total of 42 patients diagnosed via laparoscopy with initially resectable gastric cancer accompanied by positive cytology in abdominal cavity washing solution and/or low-burden peritoneal metastases (peritoneal cancer index PCI ≤10) are planned to be enrolled to undergo serplulimab combined with DOS, lenvatinib, PIPACS, and surgical treatment.
Read the detailed description
This study is a prospective, multicenter, open-label, exploratory phase II clinical trial aimed at evaluating the efficacy and safety of serplulimab combined with DOS, lenvatinib, and PIPACS in patients with oligometastatic peritoneal metastases of gastric and gastroesophageal junction adenocarcinoma. A total of 42 patients diagnosed via laparoscopy with initially resectable gastric cancer accompanied by positive cytology in abdominal cavity washing solution and/or low-burden peritoneal metastases (peritoneal cancer index PCI ≤10) are planned to be enrolled to undergo serplulimab combined with DOS, lenvatinib, PIPACS, and surgical treatment.
Combination therapy regimen: PIPAC + serplulimab + lenvatinib + DOS PIPAC surgical procedure process: Make a small midline abdominal incision to perform a mini-laparotomy. Under finger protection, insert a 5 mm balloon trocar into the right abdominal wall and suture the fascia at the small incision site. Insufflate CO₂ gas into the abdominal cavity to establish pneumoperitoneum, and under laparoscopic guidance, insert a second 10-12 mm trocar into the left upper abdomen.
Record the volume of ascites and aspirate the ascites, retaining a specimen for cytology; subsequently, perform a comprehensive laparoscopic exploration, and if necessary, insert an additional 5 mm or 10-12 mm cannula. Calculate the peritoneal cancer index (PCI). Conduct multiple tissue biopsies in different quadrants of the abdominal cavity.
The CAPNOPEN© nebulizer was inserted through the left epigastrio canulae and fixed at a 45° angle.
The chemotherapy drug (albumin-bound paclitaxel, 10.5 mg/m² body surface area, dissolved in 150 mL solution) was administered via remote control at a flow rate of 0.7 mL/second and a pressure of 200 psi.
After 30 minutes of exposure to the drug aerosol in the abdominal cavity, the aerosol is discharged from the abdominal cavity through a closed exhaust system.
Transtomation therapy: Serplulimab + Lenvatinib + DOS therapy for 3+3 cycles, with evaluation every 3 cycles. After the end of the third cycle, if the evaluation shows CR/PR/SD, continue treatment for another 3 cycles. If the evaluation shows PD, the Sub-I will decide whether to change the regimen.
After the 6th cycle, an evaluation will be conducted. If the evaluation indicates CR/PR/SD, surgery will be performed. If the evaluation indicates PD, the Sub investigator will decide whether to change the regimen.
Adjuvant therapy: Serplulimab + Lenvatinib + DOS therapy for 2 cycles, followed by serplulimab combined with S1 maintenance therapy for 6 months. Serplulimab maintenance therapy can be continued up to 1 year post-surgery based on the patient's preference.
Patients will receive therapy until disease progression, the occurrence of intolerable toxicity, subject withdrawal from the study, or whichever occurs first. If the subject is unable to tolerate the simultaneous administration of multiple drugs during combination therapy, discontinuation of one drug is permitted, allowing the patient to continue treatment with the other drug until meeting any criteria for treatment termination.
- Being tested
- Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC
- Keywords
- Gastric cancer/gastroesophageal junction cancer, PIPAC, serplulimab, oligometastatic peritoneal metastases
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPACDrug
First complete PIPAC surgical .The chemotherapy drug is albumin-bound paclitaxel, 10.5 mg/m² body surface area, dissolved in 150 mL solution .
Transtomation therapy: Serplulimab + Lenvatinib + DOS therapy for 3+3 cycles, with evaluation every 3 cycles. After the end of the third cycle, if the evaluation shows CR/PR/SD, continue treatment for another 3 cycles. If the evaluation shows PD, the Sub-I will decide whether to change the regimen.
After the 6th cycle, an evaluation will be conducted. If the evaluation indicates CR/PR/SD, surgery will be performed. If the evaluation indicates PD, the Sub investigator will decide whether to change the regimen.
Adjuvant therapy: Serplulimab + Lenvatinib + DOS therapy for 2 cycles, followed by serplulimab combined with S1 maintenance therapy for 6 months. Serplulimab maintenance therapy can be continued up to 1 year post-surgery based on the patient's preference.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery conversion rate
Surgery conversion rate
Measured: up to 6 months
Secondary outcomes (4)
pCR
Pathological Complete Remission Rate
Measured: up to 6 months
MPR
Major Pathological Remission Rate
Measured: up to 6 months
OS
Overall Survival
Measured: up to 24 months
Safety
TEAEs graded and irAEs
Measured: up to 24 months
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 start15 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (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/Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, yezaisheng, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902648
- Sponsor's protocol ID
- Scope Trail
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Serplulimab, Docetaxel, Oxaliplatin, S1 and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma: A Single Arm Multicentre Clinical Trail
- ClinicalTrials.gov ID
- NCT07902648
- Acronym / sponsor ID
- Scope Trail
- Keywords
- Gastric cancer/gastroesophageal junction cancer, PIPAC, serplulimab, oligometastatic peritoneal metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (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 study is a prospective, multicenter, open-label, exploratory phase II clinical trial aimed at evaluating the efficacy and safety of serplulimab combined with DOS, lenvatinib, and PIPACS in patients with oligometastatic peritoneal metastases of gastric and gastroesophageal junction adenocarcinoma. A total of 42 patients diagnosed via laparoscopy with initially resectable gastric cancer accompanied by positive cytology in abdominal cavity washing solution and/or low-burden peritoneal metastases (peritoneal cancer index PCI ≤10) are planned to be enrolled to undergo serplulimab combined with DOS, lenvatinib, PIPACS, and surgical treatment.
Detailed description
This study is a prospective, multicenter, open-label, exploratory phase II clinical trial aimed at evaluating the efficacy and safety of serplulimab combined with DOS, lenvatinib, and PIPACS in patients with oligometastatic peritoneal metastases of gastric and gastroesophageal junction adenocarcinoma. A total of 42 patients diagnosed via laparoscopy with initially resectable gastric cancer accompanied by positive cytology in abdominal cavity washing solution and/or low-burden peritoneal metastases (peritoneal cancer index PCI ≤10) are planned to be enrolled to undergo serplulimab combined with DOS, lenvatinib, PIPACS, and surgical treatment.
Combination therapy regimen: PIPAC + serplulimab + lenvatinib + DOS PIPAC surgical procedure process: Make a small midline abdominal incision to perform a mini-laparotomy. Under finger protection, insert a 5 mm balloon trocar into the right abdominal wall and suture the fascia at the small incision site. Insufflate CO₂ gas into the abdominal cavity to establish pneumoperitoneum, and under laparoscopic guidance, insert a second 10-12 mm trocar into the left upper abdomen.
Record the volume of ascites and aspirate the ascites, retaining a specimen for cytology; subsequently, perform a comprehensive laparoscopic exploration, and if necessary, insert an additional 5 mm or 10-12 mm cannula. Calculate the peritoneal cancer index (PCI). Conduct multiple tissue biopsies in different quadrants of the abdominal cavity.
The CAPNOPEN© nebulizer was inserted through the left epigastrio canulae and fixed at a 45° angle.
The chemotherapy drug (albumin-bound paclitaxel, 10.5 mg/m² body surface area, dissolved in 150 mL solution) was administered via remote control at a flow rate of 0.7 mL/second and a pressure of 200 psi.
After 30 minutes of exposure to the drug aerosol in the abdominal cavity, the aerosol is discharged from the abdominal cavity through a closed exhaust system.
Transtomation therapy: Serplulimab + Lenvatinib + DOS therapy for 3+3 cycles, with evaluation every 3 cycles. After the end of the third cycle, if the evaluation shows CR/PR/SD, continue treatment for another 3 cycles. If the evaluation shows PD, the Sub-I will decide whether to change the regimen.
After the 6th cycle, an evaluation will be conducted. If the evaluation indicates CR/PR/SD, surgery will be performed. If the evaluation indicates PD, the Sub investigator will decide whether to change the regimen.
Adjuvant therapy: Serplulimab + Lenvatinib + DOS therapy for 2 cycles, followed by serplulimab combined with S1 maintenance therapy for 6 months. Serplulimab maintenance therapy can be continued up to 1 year post-surgery based on the patient's preference.
Patients will receive therapy until disease progression, the occurrence of intolerable toxicity, subject withdrawal from the study, or whichever occurs first. If the subject is unable to tolerate the simultaneous administration of multiple drugs during combination therapy, discontinuation of one drug is permitted, allowing the patient to continue treatment with the other drug until meeting any criteria for treatment termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >18 years on the day of signing the Informed Consent Form;
- The subject is able to comprehend the procedures and methods of this clinical study, and voluntarily signs the informed consent form after providing full informed consent.
- Gastric or gastroesophageal junction cancer (HER2-negative) confirmed by histology or cytology;
- Diagnosed via laparoscope as initially resectable gastric cancer/gastroesophageal junction cancer, accompanied by positive cytology in abdominal cavity washing solution, and/or low-burden peritoneal metastasis (peritoneal cancer index PCI ≤ 10);
- ECOG PS 0-2, expected survival ≥3 months;
Key exclusion criteria (18 listed)
- There is distant metastasis outside the peritoneum.
- Peritoneal cancer index (PCI) > 10;
- Siewert type I squamous cell carcinoma of the gastroesophageal junction, primarily involving the esophagus;
- Presence of active central nervous system metastasis or meningitis carcinomatosa;
- There is an uncontrolled abdominal infection, intestinal obstruction, grade 3 abdominal effusion, or a risk of gastrointestinal fistula or perforation;
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 |
|---|---|---|
| Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPACFirst complete PIPAC surgical .The chemotherapy drug is albumin-bound paclitaxel, 10.5 mg/m² body surface area, dissolved in 150 mL solution . Transtomation therapy: Serplulimab + Lenvatinib + DOS therapy for 3+3 cycles, with evaluation every 3 cycles. After the end of the third cycle, if the evaluation shows CR/PR/SD, continue treatment for another 3 cycles. If the evaluation shows PD, the Sub-I will decide whether to change the regimen. After the 6th cycle, an evaluation will be conducted. If the evaluation indicates CR/PR/SD, surgery will be performed. If the evaluation indicates PD, the Sub investigator will decide whether to change the regimen. Adjuvant therapy: Serplulimab + Lenvatinib + DOS therapy for 2 cycles, followed by serplulimab combined with S1 maintenance therapy for 6 months. Serplulimab maintenance therapy can be continued up to 1 year post-surgery based on the patient's preference. | Drug | Experimental group |
Primary outcome
Surgery conversion rate
Time frame: up to 6 months
Surgery conversion rate
4 secondary outcomes
pCR
Time frame: up to 6 months
MPR
Time frame: up to 6 months
OS
Time frame: up to 24 months
Safety
Time frame: up to 24 months
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.
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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 Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC in people with Gastric/Gastroesophageal Junction Adenocarcinoma and Oligometastatic Peritoneal Metastasis, run by Fujian 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 13 inclusion and 18 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?
Surgery conversion rate (time frame: up to 6 months). 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.