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HIPECPhase 2ICI-HIPETNCT07068178

Evaluating the Efficacy of Hyperthermic Intraperitoneal Treatment to Enhance the Sensitivity of Immune Checkpoint Inhibitor in Patients With Advanced Ovarian Cancer： A Single-arm Study

A Phase 2 study testing ICI-HIPET in people with HIPEC and Ovarian Serous Adenocarcinoma, run by Jing Li at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background: Advanced ovarian cancer is a highly dangerous disease, and many patients lose their lives due to limited treatment effectiveness. Previous studies have shown that current immunotherapy (e.g., PD-1 inhibitors) has poor results in ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
HIPEC, Ovarian Serous Adenocarcinoma
What is being tested?
ICI-HIPET
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Aug 2025to Jan 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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with FIGO stage IIIC-IVA high-grade serous ovarian adenocarcinoma (histologically confirmed).
  • Aged 18-70 years.
  • Life expectancy ≥12 months.
  • CT Suidan score ≥7 and Fagotti score ≥8 (assessed by two independent gynecologic oncologists via laparoscopic evaluation).
  • Adequate organ function:AST/ALT ≤2× upper limit of normal (ULN);Total bilirubin ≤1.5× ULN;Serum creatinine ≤1.5× ULN.
  • No myelosuppression:Hemoglobin (Hb) ≥80 g/L,White blood cell count (WBC) ≥2.0×10⁹/L,Neutrophil count ≥1.0×10⁹/L,Platelet count ≥100×10⁹/L.
  • Performance Status (PS) score 0-1.

Who cannot join

  • Partial or complete bowel obstruction.
  • Intestinal fistula of any grade.
  • Hydronephrosis unrelieved by ureteral stenting.
  • History of organ transplantation.
  • Inflammatory bowel disease.
  • Active or history of autoimmune diseases (e.g., systemic lupus erythematosus).
Show all 15Show fewer
  • Prior immunotherapy (including cellular therapy) or use of immunomodulators.
  • Brain metastases.
  • Grade ≥3 venous thromboembolism.
  • Active infections (e.g., tuberculosis).
  • Prior pelvic/abdominal radiotherapy.
  • Prior hyperthermic intraperitoneal chemotherapy (HIPEC) or thermotherapy.
  • Grade ≥2 dysfunction of major organs (e.g., heart, liver, kidneys).
  • Other malignancies within 5 years (except skin or thyroid cancer).
  • Psychiatric disorders affecting compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Li, Doctor contact

+86 17701927439

lijing228@mail.sysu.edu.cn

China1 site

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

    Erwei Song, Jing Li ext. +8615915893493, lijing228@mail.sysu.edu.cn

Other trials in China

About this study

Background:

Advanced ovarian cancer is a highly dangerous disease, and many patients lose their lives due to limited treatment effectiveness. Previous studies have shown that current immunotherapy (e.g., PD-1 inhibitors) has poor results in ovarian cancer. The research team discovered that adding "heated abdominal chemotherapy" (called HIPEC, which uses a heated drug solution to wash the abdomen) to standard chemotherapy helps patients better control tumors. Recent lab studies also found that HIPEC not only reduces "harmful cells" around tumors that block drug effectiveness but also makes immunotherapy drugs work better. Animal experiments further confirmed that combining HIPEC with immunotherapy improves outcomes. Therefore, the investigators aim to test a key question: Can HIPEC help immunotherapy drugs work more effectively in humans?

Read more

Study Details:

The study will conduct a small two-phase trial, planning to enroll 30 patients with advanced ovarian cancer (Stage IIIc-IVA). All participants will receive standard chemotherapy (paclitaxel + platinum drugs) combined with HIPEC and an immunotherapy drug (tislelizumab, a PD-1 inhibitor). The main goal is to check whether tumors are completely removed after surgery. Investigators will also track how long tumors stay under control, overall survival time, treatment safety, and use blood and tumor tissue tests to find biomarkers that predict treatment response.

Why This Matters:

The study hopes to identify a safe method to enhance immunotherapy effectiveness and offer improved outcomes for advanced ovarian cancer patients.

Read the detailed description

Advanced ovarian cancer carries a high mortality rate, and improving prognosis remains a clinical challenge, particularly given the limited efficacy of immunotherapy observed in prior studies. Prior randomized controlled trial demonstrated that hyperthermic intraperitoneal chemotherapy (HIPEC) enhances the effects of neoadjuvant chemotherapy in ovarian cancer. Further preclinical studies revealed that HIPEC reduces cancer-associated fibroblasts (CAFs) in the tumor microenvironment, alleviates immunosuppressive phenotypes, and synergizes with immune checkpoint inhibitors (ICIs) in animal models. Building on this evidence, it is hypothesized that HIPEC sensitizes ovarian cancer to ICIs. This prospective single-arm trial employs a Simon's two-stage design to evaluate HIPEC combined with tislelizumab (an anti-PD-1 agent) and standard neoadjuvant chemotherapy (paclitaxel/platinum) in 30 patients with FIGO stage IIIc-IVA high-grade serous ovarian cancer. The primary endpoint is R0 resection rate, with secondary endpoints including progression-free survival, overall survival, safety, pathological response, and multi-omics biomarker exploration. The study aims to validate HIPEC's role in enhancing ICI efficacy and provide evidence for improving immunotherapy outcomes in advanced ovarian cancer.

Being tested
ICI-HIPET
Keywords
ICI-HIPET

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICI-HIPETDrug

    Patients received the following interventions: On Day 0, intravenous administration of tislelizumab (an anti-PD-1 immune checkpoint inhibitor) was initiated within 3 hours post-HIPEC. Tumor tissue samples were collected before HIPEC, at 30 minutes, 60 minutes, and 90 minutes (end of HIPEC). Serum samples were collected pre- and post-HIPEC. On Day 1, additional serum samples were collected 24 hours after HIPEC-ICI completion. From Days 2-3, patients underwent paclitaxel + carboplatin chemotherapy, with serum sampling repeated at 48 hours post-HIPEC-ICI. On Days 21 and 42, the second and third cycles of neoadjuvant chemotherapy (tislelizumab + paclitaxel + carboplatin) were administered intravenously.

Study groups in NCT07068178
Study groupRoleWhat they receive
ICI-HIPETExperimentalPatients received the following interventions: On Day 0, intravenous administration of tislelizumab (an anti-PD-1 immune checkpoint inhibitor) was initiated within 3 hours post-HIPEC. Tumor tissue samples were collected before HIPEC, at 30 minutes, 60 minutes, and 90 minutes (end of HIPEC). Serum samples were collected pre- and post-HIPEC. On Day 1, additional serum samples were collected 24 hours after HIPEC-ICI completion. From Days 2-3, patients underwent paclitaxel + carboplatin chemotherapy, with serum sampling repeated at 48 hours post-HIPEC-ICI. On Days 21 and 42, the second and third cycles of neoadjuvant chemotherapy (tislelizumab + paclitaxel + carboplatin) were administered intravenously.
Receives: Drug: ICI-HIPET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 Resection Rate

    R0 resection rate refers to the proportion of patients achieving complete macroscopic tumor removal (no visible residual disease) during interval debulking surgery after three cycles of neoadjuvant chemotherapy. This is determined by the surgeon's intraoperative assessment of the pelvic and abdominal cavities for any gross residual lesions.

    Measured: At interval debulking surgery (approximately 9-12 weeks after treatment initiation)

Secondary outcomes (4)

  1. Rate of progression-free survival

    The 1-year, 2-year, and median progression-free survival (PFS) rates of patients were calculated.

    Measured: From day 1 of treatment until progression/death, through study completion (up to 24months)

  2. Rate of overall survival

    The 1-year, 2-year overall survival (OS) rates and median OS of patients were calculated.

    Measured: From completion of first neoadjuvant therapy until death from any cause, assessed up to 24 months

  3. Pathological response rate

    Independently assessed by pathologists, defined as the absence of microscopic residual tumor in all specimens obtained during interval debulking surgery.

    Incidence of chemotherapy response score 3 (CRS3): Following three cycles of neoadjuvant therapy, patients underwent surgical debulking via laparotomy. The omental tissue was evaluated using the chemotherapy response score (CRS) system to determine the rate of CRS3 (indicating complete or near-complete pathological response).

    Measured: During pathological examination of omental tissue (within 2 weeks post-surgery)

  4. Radiological Response Rate

    Independently assessed by radiologists using baseline CT or MRI (prior to neoadjuvant therapy) as reference. Tumor changes were evaluated after three cycles of neoadjuvant therapy, categorized as follows:

    Complete Response (CR): Disappearance of all target lesions, except for nodal disease. All target nodes must shrink to normal size (short axis <10 mm). All lesions must be assessed.

    Partial Response (PR): ≥30% reduction in the sum of diameters of all measurable target lesions compared to baseline. Nodal lesions are measured by short axis, while non-nodal lesions use the longest diameter. All lesions must be assessed.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters relative to the smallest value recorded during the study (or baseline if no decrease was observed), plus an absolute increase of ≥5 mm. Appearance of new lesions also qualifies as PD.

    Stable Disease (SD): Neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD

    Measured: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionMay 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07068178
Sponsor's protocol ID
ICI-HIPET
Acronym
ICI-HIPET
Status last verified
Jul 2025
First submitted
13 Jun 2025
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Don't share IPD

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ICI-HIPET in people with HIPEC and Ovarian Serous Adenocarcinoma, run by Jing Li 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 7 inclusion and 15 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 16 Jul 2025. 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. 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?

Contact Jing Li, Doctor (+86 17701927439, lijing228@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection Rate (time frame: At interval debulking surgery (approximately 9-12 weeks after treatment initiation)). 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 NCT07068178.

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 16 Jul 2025.

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