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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AK104 with radiotherapy
DrugAK104 with radiotherapy combined with standard of therapy
Standard of therapy
DrugStandard of therapy including target therapy and chemotherapy
Treatment groups
73 Participants
are divided into 2 treatment groupsGroup A: Control groupExperimental treatment 1 intervention
Group B: Experimental groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
ORR
Objective Response Rate
Time frame
up to approximately 2 yearsSecondary outcomes
1
ETS
Early Tumor Shrink of liver metastasis by MRI
Time frame
up to approximately 2 years2
PFS
Progression free survival
Time frame
up to approximately 2 years3
OS
overall survival
Time frame
up to approximately 2 years4
R0 Resection Rate / NED Rate
Metastatic Lesion R0 Resection Rate / NED Rate
Time frame
up to approximately 2 yearsOther outcomes
1
Biomarker
Detection of related biomarkers and exploratory analysis of efficacy and prognosis
Time frame
up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov