Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Brief summary

The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Mi Jian, Zhensong Yang, Yutao Tang, Fangjie Jiang, Li Cai et al. (19 authors)

APL Bioengineering2025-08-281 citations

10.1063/5.0250475

LRRC25 Is a Potential Biomarker for Predicting Immunotherapy Response in Patients with Gastric Cancer.

Yang Z, Yu B, Hu J, Jiang L, Jian M.

2025-02-171 citations

10.1007/s10620-025-08882-7

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol

Liucheng Wu, Haiqing Yan, Yuzhou Qin, Mingwei Huang, Tingan Wang et al. (7 authors)

BMJ Open2024-02-016 citations

10.1136/bmjopen-2023-075696

Neoadjuvant therapy with immune checkpoint blockade, antiangiogenesis, and chemotherapy for locally advanced gastric cancer.

Li S, Yu W, Xie F, Luo H, Liu Z, Lv W, Shi D, Yu D, Gao P, Chen C, Wei M, Zhou W, Wang J, Zhao Z, Dai X, Xu Q, Zhang X, Huang M, Huang K, Wang J, Li J, Sheng L, Liu L.

2023-01-03163 citations

10.1038/s41467-022-35431-x

Protocol for a randomized controlled trial of perioperative S-1 plus oxaliplatin combined with apatinib and camrelizumab in patients with resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma

Yanan Zheng, Zhenqiang Wang, Chao Yan, Min Yan, Zhiguo Hou et al. (8 authors)

Annals of Translational Medicine2020-12-0117 citations

10.21037/atm-20-7802

Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial

Yanan Zheng, Xiao Yang, Chao Yan, Runhua Feng, Birendra Kumar Sah et al. (17 authors)

European Journal of Cancer2020-03-1159 citations

10.1016/j.ejca.2020.02.013

Interventions

DRUGApatinib 250mg

Apatinib 250mg

DRUGCamrelizumab

Camrelizumab 200mg

DRUGS-1, Oxaliplatin

S-1, Oxaliplatin, q3w

DRUGApatinib 500mg

Apatinib 500mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

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 (pCR)	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event-free Survival (EFS)	Up to approximately 2 years

Secondary

Measure	Time frame
Major pathological response(MPR)	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Margin-free (R0) resection rate	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
DFS	up to 2 years
OS	up to 3 years
Downstaging of N stage	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
AEs	Up to approximately 18 months

Countries

China

Contacts

PRINCIPAL_INVESTIGATORZhenggang Zhu

Ruijin Hospital

Outcome results

None listed