NCT04792515

Camrelizumab Combined With SOX and/or Apatinib for Locally Advanced Gastric Cancer

A Single-arm, Multicenter Clinical Study of Evaluating Camrelizumab Combined With SOX and/or Apatinib in the Treatment of Locally Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to evaluate the efficacy and safety of camrelizumab in combination with SOX and/or apatinib in the treatment of locally advanced gastric cancer or gastroesophageal junction adenocarcinoma.The primary endpoint was pathologic complete response (PCR).In addition, secondary efficacy endpoints include R0 resection rate, objective response rate (ORR), and 1-year progression-free survival rate (PFSR) . They were set to demonstrate the therapeutic benefit of camrelizumab combined with SOX in patients 。

Detailed description

Screening period Subjects will enter the study screening period after signing the informed consent, and the maximum screening period will be 28 days. Those who meet all the inclusion criteria and do not meet the exclusion criteria will be allowed to enter the study treatment period. Treatment period Patients received 2-4 cycles of neoadjuvant chemotherapy with camrelizumab +SOX regimen, and then received adjuvant chemotherapy with camrelizumab +SOX regimen after surgery, with a total of 8 cycles before and after surgery. Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed. Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery. Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed. Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours. Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14. The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing. Subjects will continue to receive study therapy until disease progression (PD) occurs, intolerable toxicity occurs, a new antitumor therapy is initiated, treatment is terminated after careful consideration by the patient or investigator, or they die, or are lost to follow-up. Clinical tumor evaluation during the screening period and throughout the study period will be based on RECIST version 1.1.Baseline tumor assessment was performed 28 days prior to the start of treatment.Enhanced computed tomography (CT) or magnetic resonance imaging (MRI) is recommended for tumor evaluation.Tumor efficacy evaluation was conducted every 2 cycles (±3 days) from the beginning of the first dose study until the occurrence of PD. The visit time for efficacy evaluation was fixed, regardless of whether the treatment cycle delay occurred.If treatment is discontinued for reasons other than PD, subjects will continue to undergo tumor evaluation until PD occurs, initiation of new antitumor therapy, withdrawal of informed consent, death, or loss of follow-up, whichever occurs first.In the event of clinical symptoms suggestive of PD, imaging methods should be used for subsequent evaluation in order to record and confirm tumor efficacy. From the beginning of the first dose study treatment, a systematic safety assessment was carried out for each administration cycle.During the study treatment, a basic safety assessment was performed before each administration cycle, including completion of a physical examination, vital signs, and basic laboratory tests (ECG, blood routine, urine routine, fecal occult blood, blood biochemistry, coagulation function, etc.).

Conditions

• Locally Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab combined with SOX/ or apatinib	Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed. Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery. Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed. Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours. Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14. The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2021-03-11
• Last updated: 2021-03-11

Locations

1 site across 1 country: China