Evidence map›Paper›PMID 39183277›Full record

Trial reportBMC medicine2024

Camrelizumab plus apatinib in patients with advanced or recurrent endometrial cancer after failure of at least one prior systemic therapy (CAP 04): a single-arm phase II trial.

Wenjuan Tian, Yulan Ren, Jing Lu, Chuyu Jing, Wei Zhang, Haiming Li, Tingting Wang, Zhiguo Hou, Ting Yang, Wenqing Zhu and 5 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Wenjuan Tian *Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Yulan Ren *Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Jing LuDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.
Chuyu JingDepartment of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Wei ZhangDepartment of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Haiming LiDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.
Tingting WangDepartment of Nuclear Medicine, Institute of Clinical Nuclear Medicine, Renji Hospital, Shanghai, 200127, China.
Zhiguo HouDepartment of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, 201210, China.
Ting YangDepartment of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, 201210, China.
Wenqing ZhuDepartment of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, 201210, China.
Yi ZhangDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China.
Boer ShanDepartment of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Huijuan YangDepartment of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Xi ChengDepartment of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China.
Huaying WangDepartment of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Xuhui District, Shanghai, 200032, China. wanghuayingfducc@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe combination of anti-programmed death 1 (PD-1) inhibitors and tyrosine kinase inhibitors is an effective treatment strategy in endometrial cancer. We aimed to explore the efficacy and safety of camrelizumab plus apatinib as an alternative therapeutic option in patients with previously treated endometrial cancer.

methodsThis single-arm Simon's two-stage phase II trial was conducted at the Fudan University Shanghai Cancer Center. Patients with advanced or recurrent endometrial cancer who had failed at least one prior systemic therapy were screened for potential participation. Eligible patients were treated with intravenous camrelizumab (200 mg d1 q2w) and oral apatinib (250 mg qd) every 4 weeks. The primary end point was the objective response rate (ORR) per RECIST v1.1 in the intention-to-treat principle.

resultsBetween January 20, 2020, and October 14, 2022, 36 patients (29 with microsatellite stability/mismatch repair proficient [MSS/pMMR] tumors; two with microsatellite instability-high/mismatch repair deficient [MSI-H/dMMR] tumors) were enrolled and treated. The confirmed ORR was 44.4% (95% CI: 27.9, 61.9) and the disease control rate was 91.7% (95% CI: 77.5, 98.2). The median duration of response was 9.3 (95% CI: 4.3, not reached) months, the median progression-free survival was 6.2 (95% CI: 5.3, 11.1) months, and the median overall survival was 21.0 (95% CI: 13.4, not reached) months during a median follow-up of 14.2 (interquartile range: 10.3, 27.6) months. Treatment-related adverse events of grade 3 or 4 occurred in 20 (55.6%) patients, with the most common being increased γ-glutamyl transferase (27.8%), alanine aminotransferase (16.7%) and aspartate aminotransferase (13.9%), and hypertension (11.1%). No treatment-related death occurred.

conclusionsCamrelizumab plus apatinib showed promising antitumor activity with manageable toxicity in patients with advanced or recurrent endometrial cancer who had failed at least one prior systemic therapy. The findings of this study support further investigation of camrelizumab plus apatinib as an alternative therapeutic option, especially for patients with MSS/pMMR tumors.

trial registrationThis trial was retrospectively registered with ChiCTR.org.cn, number ChiCTR2000031932.

Indexed as

Antibodies, Monoclonal, HumanizedEndometrial NeoplasmsPyridinesAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMiddle AgedNeoplasm Recurrence, LocalAntibodies, Monoclonal, HumanizedapatinibcamrelizumabPyridinesAntiangiogenic agentsAnti-programmed death 1 (PD-1) inhibitorsEndometrial cancerImmune checkpoint inhibitors

Identifiers

PMID39183277
PMCPMC11346039

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.