Clinical trial NCT06693128: Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer
Official title: Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Exploratory II Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0 (according to AJCC 8th edition) ;
2. Plans to proceed to surgery after completion of neoadjuvant therapy;
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
4. Has adequate organ function.
5. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer.
6. Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use highly effective methods of contraception during the study and for 2 months after the last administration of carrilizumab or 8 weeks after apatinib or 3 months after chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study.

Exclusion Criteria:

1. Known HER2 positive;
2. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
3. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast;
4. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)；
5. Known hypersensitivity to any of the study drugs or excipients;
6. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
7. Congenital or acquired immune deficiency (e.g. HIV infected)

Primary outcomes:
measure: Pathological Complete Response (pCR)
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Secondary outcomes:
measure: Major pathological response (MPR)
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: total Pathologic complete response (tpCR)
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: R0 resection rate
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: ypN staging
timeFrame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
measure: Event free survival (EFS)
timeFrame: Up to approximately 3 years
measure: Disease-free survival (DFS)
timeFrame: Up to approximately 3 years
measure: Overall survival(OS)
timeFrame: Up to approximately 5 years
measure: AEs
timeFrame: Up to approximately 18 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
city: Shanghai
country: China
facility: Changhai Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
Study officials:
affiliation: Ruijin Hospital
name: Zhenggang Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yantao Tian
role: PRINCIPAL_INVESTIGATOR
References: