Table I.

Summary of the efficacy data of anlotinib in key clinical trials.

Author (year)	Phase	Design	Tumor type	No. of patients	Outcomes (anlotinib vs. control)	(Refs.)
Sun et al (2016)	I	Dose escalation, open-label	Advanced refractory solid tumors	35	MTD: 12 mg qd Recommended regime: 12 mg qd, 2-week on/1-week off	(34)
Han et al (2018)	II	Randomized, multicenter, double-blind, placebo-controlled	Refractory advanced non-small-cell lung cancer	117	mPFS: 4.8 vs. 1.2 months mOS: 9.3 vs. 6.3 months	(37)
Cheng et al (2018)	II	Randomized, multicenter, double-blind, placebo-controlled	Relapsed small cell lung cancer	120	mPFS: 4.1 vs. 0.7 months mOS: Data not sufficiently mature for analysis	(38)
Chi et al (2018)	II	Multicenter, single-arm sarcoma	Refractory metastatic soft tissue	166	mPFS: 5.6 months mOS: 12 months	(43)
Sun et al (2018)	II	Multicenter, single-arm	Locally advanced or metastatic medullary thyroid carcinoma	58	PFS rate (at 48 weeks): 85.5% PR: 56.90%	(54)
Zhou et al (2019)	II	Centrally randomized, multicenter, sunitinib-controlled	Metastatic renal cell carcinoma	133	mPFS: 17.5 vs. 16.6 months mOS: 30.9 vs. 30.5 months	(62)
Huang et al (2019)	II	Randomized, multicenter, double-blind	Advanced esophageal squamous cell carcinoma	164	mPFS: 3.02 vs. 1.41 months mOS: 6.11 vs. 7.20 months DCR: 64.22% vs. 18.18%	(63)
Han et al (2018)	III	Randomized, multicenter, double-blind, placebo-controlled, parallel-arm	Advanced non-small-cell lung cancer	439	mPFS: 5.4 vs. 1.4 months	(65)

DCR, disease control rate; mOS, median overall survival; mPFS, median progression-free survival; MTD, maximum tolerated dose; PR, partial response.