PMID- 33052760
OWN - NLM
STAT- MEDLINE
DCOM- 20210402
LR  - 20240403
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 38
IP  - 34
DP  - 2020 Dec 1
TI  - Camrelizumab Plus Apatinib in Patients With Advanced Cervical Cancer (CLAP): A 
      Multicenter, Open-Label, Single-Arm, Phase II Trial.
PG  - 4095-4106
LID - 10.1200/JCO.20.01920 [doi]
AB  - PURPOSE: Camrelizumab is an antibody against programmed death protein 1. We 
      assessed the activity and safety of camrelizumab plus apatinib, a tyrosine kinase 
      inhibitor of vascular endothelial growth factor receptor-2, in patients with 
      advanced cervical cancer. METHODS: This multicenter, open-label, single-arm, 
      phase II study enrolled patients with advanced cervical cancer who progressed 
      after at least one line of systemic therapy. Patients received camrelizumab 200 
      mg every 2 weeks and apatinib 250 mg once per day. The primary end point was 
      objective response rate (ORR) assessed by investigators per RECIST version 1.1. 
      Key secondary end points were progression-free survival (PFS), overall survival 
      (OS), duration of response, and safety. RESULTS: Forty-five patients were 
      enrolled and received treatment. Median age was 51.0 years (range, 33-67 years), 
      and 57.8% of patients had previously received two or more lines of chemotherapy 
      for recurrent or metastatic disease. Ten patients (22.2%) had received 
      bevacizumab. Median follow-up was 11.3 months (range, 1.0-15.5 months). ORR was 
      55.6% (95% CI, 40.0% to 70.4%), with two complete and 23 partial responses. 
      Median PFS was 8.8 months (95% CI, 5.6 months to not estimable). Median duration 
      of response and median OS were not reached. Treatment-related grade 3 or 4 
      adverse events (AEs) occurred in 71.1% of patients, and the most common AEs were 
      hypertension (24.4%), anemia (20.0%), and fatigue (15.6%). The most common 
      potential immune-related AEs included grade 1-2 hypothyroidism (22.2%) and 
      reactive cutaneous capillary endothelial proliferation (8.9%). CONCLUSION: 
      Camrelizumab plus apatinib had promising antitumor activity and manageable 
      toxicities in patients with advanced cervical cancer. Larger randomized 
      controlled trials are warranted to validate our findings.
FAU - Lan, Chunyan
AU  - Lan C
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Shen, Jingxian
AU  - Shen J
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
AD  - Department of Radiology, Sun Yat-sen University Cancer Centre, Guangzhou, China.
FAU - Wang, Yin
AU  - Wang Y
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Li, Jundong
AU  - Li J
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Liu, Zhimin
AU  - Liu Z
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - He, Mian
AU  - He M
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen 
      University, Guangzhou, China.
FAU - Cao, Xinping
AU  - Cao X
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
AD  - Department of Radiotherapy, Sun Yat-sen University Cancer Centre, Guangzhou, 
      China.
FAU - Ling, Jiayu
AU  - Ling J
AD  - Department of Medical Oncology, Sixth Affiliated Hospital, Sun Yat-sen 
      University, Guangzhou, China.
FAU - Huang, Jiaming
AU  - Huang J
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen 
      University, Guangzhou, China.
FAU - Zheng, Min
AU  - Zheng M
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Zou, Guorong
AU  - Zou G
AD  - Department of Radiotherapy, Panyu Central Hospital, Guangzhou, China.
FAU - Yan, Haowen
AU  - Yan H
AD  - Department of Radiotherapy, Panyu Central Hospital, Guangzhou, China.
FAU - Liu, Qing
AU  - Liu Q
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
AD  - Department of Cancer Prevention Centre, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
FAU - Yang, Fan
AU  - Yang F
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Wei, Wei
AU  - Wei W
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Deng, Yanhong
AU  - Deng Y
AUID- ORCID: 0000-0001-6873-8026
AD  - Department of Medical Oncology, Sixth Affiliated Hospital, Sun Yat-sen 
      University, Guangzhou, China.
FAU - Xiong, Ying
AU  - Xiong Y
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
FAU - Huang, Xin
AU  - Huang X
AUID- ORCID: 0000-0001-9775-5618
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Centre, 
      Guangzhou, China.
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Centre 
      for Cancer Medicine, Guangzhou, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03816553
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201014
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyridines)
RN  - 5S371K6132 (apatinib)
RN  - 73096E137E (camrelizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Middle Aged
MH  - Progression-Free Survival
MH  - Protein Kinase Inhibitors/administration & dosage
MH  - Pyridines/administration & dosage/adverse effects
MH  - Survival Rate
MH  - Uterine Cervical Neoplasms/*drug therapy/pathology
PMC - PMC7768345
EDAT- 2020/10/15 06:00
MHDA- 2021/04/07 06:00
PMCR- 2021/12/01
CRDT- 2020/10/14 17:58
PHST- 2020/10/15 06:00 [pubmed]
PHST- 2021/04/07 06:00 [medline]
PHST- 2020/10/14 17:58 [entrez]
PHST- 2021/12/01 00:00 [pmc-release]
AID - 2001920 [pii]
AID - 10.1200/JCO.20.01920 [doi]
PST - ppublish
SO  - J Clin Oncol. 2020 Dec 1;38(34):4095-4106. doi: 10.1200/JCO.20.01920. Epub 2020 
      Oct 14.