Clinical trial NCT05669807: Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
Official title: A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Second Line Treatment of Gastric Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-01-03
Enrollment: 184
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Objective Response Rate
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until the date of date of death from any cause, assessed up to 24 months
measure: Progression-free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Treatment related adverse reactions
timeFrame: 24 months
measure: Quality of life assessment
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Ji Zhu
role: PRINCIPAL_INVESTIGATOR
References: