Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

NCT ID: NCT05669807

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2025-11-30

Brief Summary

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Conditions

Second Line Treatment of Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Camrelizumab+Albumin-bound paclitaxel

Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

200mg d1, the first day, every 14 days as a cycle

Albumin-Bound Paclitaxel

Intervention Type: DRUG

100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle

B: Camrelizumab+Irinotecan

Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

200mg d1, the first day, every 14 days as a cycle

Irinotecan

Intervention Type: DRUG

180 mg/m2, the first day, every 14 days as a cycle

Interventions

Camrelizumab

200mg d1, the first day, every 14 days as a cycle

Intervention Type: DRUG

Albumin-Bound Paclitaxel

100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle

Intervention Type: DRUG

Irinotecan

180 mg/m2, the first day, every 14 days as a cycle

Intervention Type: DRUG

Other Intervention Names

Camrel; ABP; Iri

Eligibility Criteria

Inclusion Criteria

• Age: 18-75
• ECOG score: 0 or 1
• Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
• histologically proven adenocarcinoma
• Received chemotherapy based on platinum and fluorouracil within 12 months
• Patients not previously treated with paclitaxel or irinotecan
• Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit)
• Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min
• Echocardiography or radionuclide cardiac function test, LVEF ≥ 50%
• Expected survival ≥ 3 months
• Sign the informed consent form

Exclusion Criteria

• Patients who have received irinotecan or paclitaxel chemotherapy in the past
• ECOG PS score:>2
• Advanced gastric cancer patients with extensive and severe peritoneal metastasis
• Patients with severe liver and kidney insufficiency or cardiac insufficiency
• HIV positive, active hepatitis B or C, active pulmonary tuberculosis
• Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc
• Patients known to be allergic to any of the study drugs
• Pregnant or lactating female patients

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji Zhu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji Zhu

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Central Contacts

Ji Zhu

Role: CONTACT

leo.zhu@126.com

0571-88128142

Jinwen Shen

Role: CONTACT

shenjw2005@126.com

0571-88128142

Other Identifiers

CARTOnG-2101

Identifier Type: -

Identifier Source: org_study_id