Share: Circulating-JAPAN,

The CirCulating-JAPAN test has been mentioned many times in recent major forums and academic conferences. It is the largest forward-looking, multi-center, and MRD-guided CRC-aided therapy test. Used to improve adjuvant treatment of colorectal cancer. The test includes three clinical trials: Gakaxy Research, Vega Research and Altair Studies.

Galaxy Research

Galaxy Study is a forward -looking large -scale national registration study that aims to monitor the CTDNA status of clinical II to Phase IV CRC patients that can be subject to surgical resection. This study uses personalized and tumor information CTDNA detection from Natera, INC (customized, MPCR-NGS). It will collect blood samples 4, 12, 24, 36, 48, 72, and 96 weeks before and after surgery. Computer tomography (CT) will be performed every 6 months after surgery for 7 years. The researchers will receive the results of the CTDNA test in time and consider incorporating the patient into the Vega or Altair test according to the CTDNA state. The tissue samples fixed for residual blood, frozen and Fort Marin are used for further analysis, including RNA sequencing, and a total of 2,500 patients will be recruited.

Vega test

The VEGA test is a random III study, which aims to test whether the surgery of simple postoperative surgery is not inferior to the standard CAPOX therapy. Patients are randomly assigned to a separate surgery (observation group) or received 3 months of CAPOX treatment at a proportion of 1: 1 (control group: 1-14 days Capecitabine, 2000 mg/m²/day, and Oxaliplatin 130 mg every 3 times a week. /m d/d). Based on age (<70 VS ≥70 years), installment (high -risk II phase VS low -risk III stage), primary tumor position (right VS left VS rectum sigmoid colon) and RAS status (mutant and wild type) randomized grouping group Essence The main ending is the stage of disease -free survival (DFS). The key secondary end points include the time for treatment failure, total survival, adverse events, relative dose strength, and CTDNA status of each time point. After entering the group for 7 years, a contrast agent enhanced CT every 6 months.

Altair test

The Altair test is a random, double -blind, and III study. It is targeted at the 2 -year time after receiving resection and passed the SIGNATERA test to display CTDNA -positive CRC patients. The purpose is to observe the Trifluridine/Tipiracil (FTD/TPI ) There are superiority compared to the placebo. Patients will randomly allocate a 6-month oral FTD/TPI (35 mg/m², on the 1-5 and 8-12 days of the 28-day cycle) at a ratio of 1: Dose group. Randomly (<70 VS ≥70 years old), installment (phase II or below VS III stage vs IV or M1), primary tumor position (right VS left colon vs vs rectal), CTDNA status in January ( Positive, negative, or unknown group) and institutions. The main end point is DFS. The key endpoints include the conversion rate, overall survival, adverse events and quality of life from positive to negative CTDNA status.

It can be seen from the above that the CirCulating-JAPAN includes the "downgrade" and "upgrade" test for CTDNA negative and positive patients, and helps to answer whether the CTDNA has prognosis and/or predictive value after surgery. Here, the "downgrade" and "upgrade" test for CTDNA negative and positive patients is of great significance. It is a precise development of tumor clinical treatment solutions.

Similarly, the clinical application of MRD is also very hot in China. The diagnostic companies on the head have entered the track. Various multi -centered, forward -looking, and multi -indications clinical trials have been carried out in China one after another.

As described in the previous article "MRD testing for CTDNA, have you participated? ", The technical route for MRDs is mainly divided into: Tumor-Assays (unknown analysis of tumor) and TUMOR-Informed Assays (tumor knowledge/priority analysis). Ability and stability, in addition to the way we can use ultra-deep-enlarged additions, we can also try to mutate the enrichment of Reads (such as BDA technology); at the same time, we can also adopt Sample-level strategies to improve sensitivity and specificity , Similar to Natera's SIGNTERA, using 16 digits of algorithms, setting a reasonable Cut-OFF, whether it is an ultra-depth NGS or multiple DPCR technologies with mutation and rich enrich Become normal.

When the detection of MRD becomes normal, the auxiliary treatment after the operation is not only added, but also subtraction, which can truly achieve precise personalized personal diagnosis and treatment.