OncoMatch/Clinical Trials/NCT06313801
Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
Is NCT06313801 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for gastric cancer.
Treatment: Docetaxel · Oxaliplatin · Calcium folinate · Fluorouracil · dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)). — After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered. After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative tumor status
Her2-neu negative tumor status
Disease stage
Required: Stage M1 (WITH THE ONLY MANIFESTATION OF M1 IN THE FORM OF - CY+ IN INITIAL PERITONEAL LAVAGE AND/OR PERITONEAL DISSEMINATION PCI <16)
Excluded: Stage M1 WITH THE EXCEPTION OF CY+ IN INITIAL PERITONEAL LAVAGE AND/OR PERITONEAL DISSEMINATION PCI <16, PCI ≥16
Metastatic disease required
Verified gastric cancer (adenocarcinoma, ring-cell carcinoma) with the presence of M1 (with the only manifestation of M1 in the form of - Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI <16)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any specific antitumor treatment for stomach cancer and/or other malignant tumor
Exception: except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease
Any specific antitumor treatment for stomach cancer and /or other malignant tumor in the anamnesis (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease)
Cannot have received: specialized treatment for stomach cancer
Previous specialized treatment for stomach cancer
Lab requirements
Blood counts
evaluation of hemoglobin, neutrophils, platelets
Kidney function
evaluation of urea, creatinine
Liver function
evaluation of ast, alt, total bilirubin
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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