Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Conditions
Brief summary
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.
Interventions
RADIATIONPreoperative Radiotherapy
Radiotherapy 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.
DRUGApatinib+Camrelizumab+SOX
Apatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy. * Has life expectancy of greater than 12 months.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response | Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response(MPR) | Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment |
| Margin-free (R0) resection rate | Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment |
| Lymph node status after neoadjuvant therapy (ypN staging) | Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment |
| Total Pathological Complete Response (tpCR) | Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment |
| OS | up to 2 years |
| Local control rate | up to 2 years |
| AEs | Up to approximately 18 months |
| DFS | up to 2 years |
Countries
China
Contacts
Primary ContactShu-Bei Wang, MD
Backup ContactGang Cai, MD
Outcome results
None listed