Preliminary exploration of programmed death 1 inhibitor combined with fruquintinib and docetaxel for advanced colorectal cancer

Table 1 Baseline characteristics of 13 patients included in this study, n (%)

Characteristics
Gender
Male	9 (69.2)
Female	4 (30.8)
Age, years
< 65	6 (46.2)
≥ 65	7 (53.8)
Underlying chronic diseases
Positive	8 (61.5)
Negative	5 (38.5)
RAS mutation
Positive	5 (38.5)
Negative	3 (23.1)
Unknown	5 (38.5)
Radical surgery
Positive	3 (23.1)
Negative	10 (76.9)
Number of metastatic sites
1	4 (30.8)
≥ 2	9 (69.2)
ECOG performance status score
0	9 (69.2)
1	4 (30.8)

ECOG: Eastern Cooperative Oncology Group.

Table 2 Efficacy of intention-to-treat population and per-protocol population, n (%)

Respond	ITT population		PP population
	2 cycles	4 cycles	2 cycles	4 cycles
PR	2 (15.4)	0	2 (20.0)	0
SD	6 (46.2)	6 (46.2)	6 (60.0)	6 (60.0)
PD	2 (15.4)	4 (30.8)	2 (20.0)	4 (40.0)
ORR	2 (15.4)	0	2 (20.0)	0
DCR	8 (61.5)	6 (46.2)	8 (80.0)	6 (60.0)

ITT: Intention-to-treat; PP: Per-protocol; PR: Partial response; SD: Stable disease; PD: Progressive disease; ORR: Objective response rate; DCR: Disease control rate.

Table 3 Adverse events in 13 patients with advanced microsatellite stable/proficient mismatch repair colorectal included in this study, n (%)

Adverse events	Grade 1	Grade 2	Grade 3	Grade 4
Nausea	0	2 (15.4)	0	0
Neutropenia	3 (23.1)	0	0	0
Fatigue	1 (7.7)	1 (7.7)	0	0
Rash	1 (7.7)	1 (7.7)	0	0
Hypothyroidism	1 (7.7)	0	0	0
Lower gastrointestinal hemorrhage	0	0	1 (7.7)	0
Immune-related myocarditis	0	1 (7.7)	0	0

Table 4 Clinical trial data for third-line treatment in advanced microsatellite stable/proficient mismatch repair colorectal cancer

Ref.	Treatment	mPFS, months	mOS, months	DCR, %	≥ grade 2 AE, %
CONCUR[3]	Regorafenib	3.2	8.8	51.0	54.0
TERRA[4]	TAS-102	2.0	7.8	44.0	45.8
FRESCO[6]	Fruquintinib	3.7	9.3	62.0	46.0
RAMTAS/IKF643 (ESMO 2024 LBA25)	TAS-102 + ramucirumab	2.37	7.46	39.4	55.9
SUNLIGHT[17]	TAS-102 + bevacizumab	5.6	10.8	76.6	72.0
RIN[18]	Regorafentib + ipilimumab + nivolumab	4.0	20.0	62.1	65.5 (irAE)
CAPability-01[15]	Chidamide + bevacizumab + PD-1	3.7	12.0	56.3	60.0
REGONIVO[14]	Regorafenib + nivolumab	7.9	NR	-	40

mPFS: Median progression-free survival; mOS: Median overall survival; DCR: Disease control rate; AE: Adverse event; PD-1: Programmed death 1; NR: Not reported; irAE: Immune-related adverse event.