Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Oesophagogastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
Plans to proceed to surgery following pre-operative chemotherapy. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Has adequate organ function.
Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
Disqualifiers
Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
Known hypersensitivity to any of the study drugs or excipients.
Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
Congenital or acquired immune deficiency (e.g. HIV infected)
Trial design
Design model
Single group
Treatments tested in this trial
Apatinib+Camrelizumab+SOX
DrugApatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w
Preoperative Radiotherapy
RadiationRadiotherapy was administered using IMPT or IMRT. The target volume includes the gastric lesion, and regional lymph nodes. A regimen of 41.4 Gy in 23 fractions is preferred.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Arm 1Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Pathological Complete Response
Time frame
Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatmentSecondary outcomes
1
Total Pathological Complete Response (tpCR)
Time frame
Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment2
Major pathological response(MPR)
Time frame
Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment3
Margin-free (R0) resection rate
Time frame
Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment4
Lymph node status after neoadjuvant therapy (ypN staging)
Time frame
Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatmentSponsors and contacts
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Source ClinicalTrials.gov