An update to "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gastrointestinal cancer,” published in Journal for ImmunoTherapy of Cancer (JITC), is now available.
In accordance with the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs), SITC CPGs undergo periodic evaluation to assess if new evidence necessitates modifications to recommendations, treatment algorithms, or other guideline content. This is done through our “SITC Living Guidelines” rapid update protocols designed to ensure SITC’s CPGs are up-to-date with cutting-edge thinking and incorporate the leading expert guidance in cancer immunotherapy care – a vital service to treating clinicians and those along the whole cancer care continuum.
Rapid Update v1.1 Summary
- Based on the FDA approvals and practice-changing data listed below, updates have been made to the guideline's narrative text, recommendations, Figure 1A, Figure 1B, Figure 2, Table 2, and Table 3.
- The FDA approved nivolumab in combination with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in April 2025.
- The FDA approved tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1) in December 2024.
- The FDA approved zolbetuximab-clab in combination with platinum and fluoropyrimidine-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test in October 2024
- The FDA approved tislelizumab for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-L1 inhibitor in March 2024.
- The indication of pembrolizumab with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma was restricted to patients with CPS greater than or equal to 1, as determined by an FDA-approved test, in November 2023.
- The FDA approved pembrolizumab with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in November 2023.
- The FDA approved pembrolizumab with gemcitabine and cisplatin for the treatment of locally advanced unresectable or metastatic biliary tract cancer (BTC) in October 2023.
- Additional changes made to address practice-changing data and updates in the field.
How to View the Living Guideline Rapid Update
Through the use of an innovative technology, rapid updates are swiftly integrated into our existing published guidelines in a clear and concise manner. An overlay system highlights affected content and provides new text reflecting the updated Expert Panel guidance, as well as important supporting information, data, and references, as applicable. These rapid updates show the progression of the changes by using a version numbering system that accompanies each new posted update.
- View Update v1.1 as an overlay to the original publication in JITC
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