Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Recurrence

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Oxaliplatin

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle.

Participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.

Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle.

Camrelizumab plus Apatinib and SOX

Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.

Camrelizumab plus Apatinib

Xiaotian Zhang

This is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Camrelizumab combined with Apatinib and standard chemotherapy will be given to treatment-naïve participants; Camrelizumab combined with Apatinib will also be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Response Rate (ORR).

This study will have 2 cohorts. In Cohort 1, participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. In Cohort 2, participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. A Simon two-stage phase II design was used for the sample size Calculation.

Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

A Prospective, Non-randomized, Multicenter, Phase II Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Unresectable Recurrent or Metastatic Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.

ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to iRECIST 1.1 based on investigator assessment.

DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.

DOR was defined as the time from first documented evidence of CR or PR until disease progression (according to RECIST 1.1 )or death due to any cause, whichever occurs first.

PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.

DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to iRECIST 1.1 based on investigator assessment.

DOR was defined as the time from first documented evidence of CR or PR until disease progression (according to iRECIST 1.1) or death due to any cause, whichever occurs first.

PFS was defined as the time from randomization to the first documented disease progression per iRECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.

OS was defined as the time from randomization to death due to any cause.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received. The grade of AE will be assessed per CTCAE 5.0.

Spots Global Cancer Trial Database for camrelizumab plus apatinib and sox