RAK cell therapy for late-stage gastric cancer

The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial

This study will test whether umbilical cord blood–derived RAK cell therapy can help adults with late-stage or recurrent gastric cancer live longer and tolerate treatment after frontline therapies have failed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07212933 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–70 with confirmed stage IV gastric or gastroesophageal junction adenocarcinoma, measurable disease by RECIST 1.1, and documented progression after prior frontline therapy are the intended participants.

Not a fit: Patients with early‑stage disease, poor performance status (ECOG >3), life expectancy under one month, or who have not yet failed frontline therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, RAK cell therapy could extend progression‑free and overall survival and provide a new option for patients with recurrent or metastatic gastric cancer after frontline treatment fails.

How similar studies have performed: Adoptive cell therapies such as NK or activated killer cells have shown promising signals in small early‑phase studies for some solid tumors, but robust evidence of benefit in late‑stage gastric cancer remains limited and the approach is still investigational.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: HongYi Liu, Prof.

Conditions Gastric Cancer; Biological Therapy; Immunotherapy; Gastric cancer; late-stage; progression-free survival; chemotherapy; T cell biological therapy