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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04208347
Collaborator
(none)
580
Enrollment
23
Locations
3
Arms
67.4
Anticipated Duration (Months)
25.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
580 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial
Actual Study Start Date :
Dec 18, 2019
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apatinib and Camrelizumab and S-1 and Oxaliplatin

Drug: Apatinib 250mg
Apatinib 250mg

Drug: Camrelizumab
Camrelizumab 200mg

Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Experimental: Apatinib and S-1 and Oxaliplatin

Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w

Drug: Apatinib 500mg
Apatinib 500mg
Active Comparator: S-1 and Oxaliplatin

Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w

Outcome Measures

Primary Outcome Measures

  1. Pathological Complete Response (pCR) [Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]

  2. Event-free Survival (EFS) [Up to approximately 2 years]

Secondary Outcome Measures

  1. Major pathological response(MPR) [Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]

  2. Margin-free (R0) resection rate [Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]

  3. DFS [up to 2 years]

  4. OS [up to 3 years]

  5. Downstaging of N stage [Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment]

  6. AEs [Up to approximately 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Hebei University Baoding China
2 Cancer Hospital Chinese Academy of Medical Sciences Beijing China
3 Xiangya Hospital Central South University Changsha China
4 Heping Hospital Affiliated to Changzhi Medical College Changzhi China
5 Sichuan Cancer Hospital & Institute Chengdu China
6 Sichuan Provincial People's Hospital Chengdu China
7 The Affiliated Hospital of Guizhou Medical University Guiyang China
8 Hainan Cancer Hospital Haikou China
9 Cancer Hospital of the University of Chinese Academy of Sciences Hangzhou China
10 The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China
11 Hefei Cancer Hospital, Chinese Academy of Sciences Hefei China
12 Lanzhou University Second Hospital Lanzhou China
13 Changhai Hospital Shanghai China
14 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai China
15 Liaoning Cancer Hospita & Institute Shenyang China
16 The Fourth Hospital of Hebei Medical University Shijiazhuang China
17 Jilin Guowen Hospital Siping China
18 Shanxi Provincial Cancer Hospital Taiyuan China
19 First Affiliated Hospital of Xi'an Jiaotong University Xian China
20 Tangdu Hospital Xian China
21 Yantai Yuhuangding Hospital Yantai China
22 Henan Provincial Cancer Hospital Zhengzhou China
23 Affiliated Hospital of Jiangsu University Zhenjiang China

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

  • Principal Investigator: Zhenggang Zhu, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT04208347
Other Study ID Numbers:
  • DRAGON - IV
  • Ahead-G208
First Posted:
Dec 23, 2019
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenocarcinoma
Oxaliplatin
Apatinib

Study Results

No Results Posted as of Jul 13, 2022