Nivolumab Combined With SOX Used in the Perioperative Treatment

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiangdong Cheng

About this trial

To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;

Previous or concurrent other malignancy;

Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.)

Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;

Trial design

Design model

Single group

Treatments tested in this trial

  • nivolumab combined with SOX

    Drug

    nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles);

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: nivolumab combined with SOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pathological complete response rate (pCR)

pCR

Time frame
3 months

Secondary outcomes

1

3-year DFS

3-year DFS

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangdong Cheng

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution