RAK cell therapy for late-stage gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial begins with a dose‑escalation phase to identify the maximum tolerated dose of RetroNectin‑activated killer (RAK) cells derived from human umbilical cord blood. After dose finding, participants enter a randomized, double‑blind Phase 2 comparison of RAK cell therapy versus a control treatment (including TAS‑102), with both patients and investigators blinded to allocation. Key endpoints are overall survival, progression‑free survival, and the incidence and severity of adverse events assessed by RECIST 1.1 and standard safety reporting. The study enrolls adults with confirmed stage IV gastric or gastroesophageal junction adenocarcinoma who have progressed after prior frontline therapy and is conducted at Chinese PLA General Hospital centers in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Subjects voluntarily join this study and sign the informed consent form. 2. Age ≥18 years and ≤70 years. 3. Confirmed by gastroscopic pathology or imaging (enhanced CT/PET-CT) as Stage IV gastric cancer or gastroesophageal junction adenocarcinoma (cTanyNanyM1). Metastatic sites include but are not limited to: liver, peritoneum, lungs, pancreas, greater omentum, retroperitoneal lymph nodes, etc.

  4\. Failure or disease progression after prior frontline anti-tumor therapy (including ineffective first- and second-line chemotherapy, targeted therapy, and immunotherapy for advanced gastric cancer).

  5\. Have measurable solid tumors (efficacy evaluation standard: RECIST 1.1); tumor assessment via CT scan or MRI must be performed within 28 days before treatment.

  6\. Physical performance status ECOG 0-3. 7. Expected lifespan ≥1 month. 8. Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

Exclusion Criteria:

* 1\. Concurrent other types of malignancy. 2. Severe cardiac, pulmonary, or cerebral system diseases. 3. Expected survival \<1 month. 4. Laboratory investigations indicating unsuitability for receiving anti-tumor biotherapy:

  1. Moderate to severe bone marrow suppression: (HGB \<80 g/L; WBC \<2.0×10⁹/L; ANC \<1.0×10⁹/L; PLT \<50×10⁹/L).
  2. Significantly decreased liver function (Child-Pugh Grade C).
  3. Severe renal insufficiency (CKD Stage III and above).
  4. Severe coagulation dysfunction (INR ≥1.5 or APTT \>1.5 × ULN).

Where it's running

• The First＆Fifth Medical Center of Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: HongYi Liu, Prof.
• Email: yunhe_gao301@163.com
• Phone: 86-010-66937523

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.