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Rectal Neoplasms

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Oxaliplatin

Capecitabine

Antimetabolites

Safety run-in phase: Fruquintinib 4mg/d, oral, once daily, continuous treatment for 2 weeks, 1 week off, q3w, 6 cycles; If the number of patients experiencing dose-limiting toxicity (DLT) was ≤1, the study would continue at that dose level. If the number of patients with DLTs was \>1, the dose of fruquintinib was decreased to 3mg/d, qd po, d1-14, q3w, and the dose expansion phase was continued；Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;

Dose expansion phase: Fruquintinib RP2D, qd po, d1-14, q3w, 6 cycles; Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;

Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine

zhenyu Lin, Ph.D

Tao Zhang, Ph.D

KaiXiong Tao, Ph.D

Zhenyu Lin, Ph.D

To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.

This study was a multicenter, single-arm, open-label clinical trial. The study included a screening period (within 21 days after signing the informed consent form to the first treatment), a treatment period (including total neoadjuvant and surgical treatment), and a follow-up period (including safety and survival follow-up).

Total neoadjuvant therapy:

* Short-course radiotherapy followed by 6 cycles of fuquinitinib combined with adbelimumab and CAPOX followed by surgical resection after 1 week of rest;
* A treatment time window of ±3 days was allowed during the study treatment, but within 3 days before each treatment, in addition to the required imaging examinations, participants were required to complete laboratory tests, physical examinations (as needed), ECOG scores and other safety assessments to determine that they could still tolerate the study treatment. The safety of the subjects was continuously assessed during the study.
* Total Mesorectal Excision (TME) is recommended for radical resection of rectal cancer.

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (UNION PRECISION-I)

The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes, also defined as the proportion of subjects with grade 0 in the AJCC Tumor Regression Grading (TRG) scoring system(version 8.0).

The percentage of patients without disease recurrence or progression or death due to any cause after 3-year follow-up

The time from the date of randomization to the death caused by any cause

The rate of negative margin microscopically

Adverse events (AEs) were graded according to the NCI CTCAE version 5·0

Spots Global Cancer Trial Database for fruquintinib, adebrelimab, oxaliplatin, capecitabine