Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
Immunotherapy, gastric cancer, gastroesophageal junction adenocarcinoma, PD-1/CTLA-4
Brief summary
The goal of this clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-paclitaxel in the second-line treatment of patients with advanced gastric/gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1. Can the combination of Iparomlimab/Tuvonralimab and albumin-paclitaxel for advanced gastric cancer/gastroesophageal junction cancer who has progressed or is intolerant to first-line SOC prolong the PFS and OS, improve ORR, DCR, and prolong DoR; 2. Whether Iparomlimab/Tuvonralimab ( anti PD-1/CTLA-4) combined with albumin-paclitaxel for second-line treatment remains effective for patients who have progressed from first-line PD-1±chemotherapy; 3. The safety and tolerability of Iparomlimab/Tuvonralimab in combination with albumin-paclitaxel for second-line treatment.Participants will:1. Use Iparomlimab/Tuvonralimab 5.0mg/kg, D1, Q3W; At least 30 minutes later, administer the chemotherapy albumin-paclitaxel: 260mg/m², D1, Q3W, and complete the infusion within 30 minutes. The combined regimen was administered every 3 weeks, with efficacy evaluated every 2 cycles (RECIST 1.1) until disease progression, intolerable toxicity or patient withdrawal.
Interventions
DRUGIparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel
Iparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W
Sponsors
Qingxia Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75; * ECOG PS 0-2; * Histologically confirmed advanced of the gastric cancer/gastroesophageal junction adenocarcinoma; * Failure of first-line treatment: Progression or intolerance after receiving platinum-based (oxaliplatin/cisplatin) + fluorouracil (5-FU/ capecitabine /S-1) regimens; * The first-line use of PD-1 inhibitors is permitted; * At least one measurable lesion (RECIST v1.1); * Good organ function (ANC≥1.5×109/L, PLT≥100×109/L, with normal liver and kidney functions）.
Exclusion criteria
* Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma; * Active autoimmune disease; * Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival（PFS） | 3 years | Assessed by INV based on RECIST 1.1, defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival（OS） | 4 years | Defined as the time between the date of enrollment and the date of death (by any cause). |
| Objective response rate（ORR） | 3 years | Defined as the percentage of participants whose BOR is either a confirmed CR or PR（assessed by INV based on RECIST 1.1） |
| Disease control rate（DCR） | 3 years | Defined as the percentage of participants who have a BOR of CR, PR, SD, or NON-CR/NON-PD（assessed by INV based on RECIST 1.1） |
| Duration of Responce （DoR） | 4 years | Defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first（assessed by INV based on RECIST 1.1） |
| Adverse events | 4 years | Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants |
Countries
China
Contacts
Primary ContactQingxia Li, Professor
Outcome results
None listed