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

University of Chinese Academy Sciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Second Line Treatment of Gastric Cancer

Treatments: Drug: Irinotecan; Drug: Camrelizumab; Drug: Albumin-Bound Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT05669807

CARTOnG-2101

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

A: Camrelizumab+Albumin-bound paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Albumin-Bound Paclitaxel

Drug: Camrelizumab

B: Camrelizumab+Irinotecan

Experimental group

Description:

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

Treatment:

Drug: Camrelizumab

Drug: Irinotecan