AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a prospective, randomized controlled, single-center phase II clinical study. It aims to compare the efficacy of AK104 plus radiotherapy combined with standard therapy versus standard therapy as first-line treatment for liver metastases from metastatic colorectal cancer.
Eligibility criteria
Qualifiers
Age ≥ 18 years, with no gender restriction;
Histologically or cytologically confirmed colorectal cancer;
Presence of liver metastases, with at least one measurable target lesion (per RECIST 1.1 criteria) in addition to a single liver metastatic lesion amenable to radiotherapy; patients with initially resectable colorectal cancer liver metastases are excluded;
Treatment-naive patients; or patients with postoperative recurrence who have not received any anti-tumor therapy within 6 months and at least 6 months have elapsed since the last adjuvant chemotherapy;
Disqualifiers
History of other malignancy within 3 years prior to enrollment, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Symptomatic brain or meningeal metastases, except those treated locally and stable for more than 2 months without symptoms.
Presence of gastrointestinal obstruction, gastrointestinal bleeding (≥+++ fecal occult blood), or perforation.
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, CD137, or CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulatory or checkpoint pathways.
Trial design
Treatments tested in this trial
- AK104 with radiotherapy
- Standard of therapy
Treatment groups
73 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov