Evidence map›Paper›PMID 39615484›Full record

Trial reportCell reports. Medicine2024

Toripalimab plus anlotinib in patients with recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm phase 2 trial (TORAL).

Yuchen Zhang, Qihua Zou, Baitian Zhao, Ning Su, Zhihua Li, Xicheng Wang, Panpan Liu, Xiaopeng Tian, Xiaojie Fang, Jun Cai and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cell reports. Medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04996758 (An Open-Label, Phase Ⅱ Study of Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 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.

NCT04996758 phase2completednot on this map

An Open-Label, Phase Ⅱ Study of Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy (TORAL)

TypeinterventionalSponsorSun Yat-sen UniversityRan2021 to 2024Enrolled40ConditionsNasopharyngeal Carcinoma, Recurrent or Metastatic Nasopharyngeal CarcinomaArmsToripalimab and Anlotinib
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

14 authors.

Yuchen ZhangState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Qihua ZouState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Baitian ZhaoState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Clinical Research, Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.
Ning SuDepartment of Oncology, Guangzhou Chest Hospital, Guangzhou 510095, P.R. China.
Zhihua LiDepartment of Oncology, Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, P.R. China.
Xicheng WangDepartment of Oncology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangdong Pharmaceutical University, Guangzhou 510062, P.R. China.
Panpan LiuState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Xiaopeng TianState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Xiaojie FangState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Jun CaiState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Clinical Research, Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.
Lirong LiState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Yingxian LiuState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Yi XiaState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. Electronic address: xiayi@sysucc.org.cn.
Qingqing CaiState Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China; Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China. Electronic address: caiqq@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment options for patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) after failure of platinum-based therapy are limited. In this phase 2 trial, 40 patients with RM-NPC who failed platinum-based chemotherapy receive toripalimab plus anlotinib regimen. The objective response rate is 37.5%, and the disease control rate is 85.0%. With a median follow-up of 17.4 months, the median progression-free survival (PFS) is 9.5 months and 1-year overall survival rate is 73.3%. The most common treatment-related grade 3-4 adverse events are hand-foot syndrome (22.5%) and oral mucositis (17.5%). Analyses of plasma circulating tumor DNA (ctDNA) demonstrate that the blood tumor mutation burden at cycle 1/2 is associated with response and PFS, and disease progression indicated by ctDNA precedes radiological progression by a median of 2.3 months. In conclusion, toripalimab plus anlotinib is well tolerated and shows promising efficacy in patients with RM-NPC, and ctDNA could be a potential predictive biomarker. The trial is registered at ClinicalTrials.gov (NCT04996758).

Indexed as

Antibodies, Monoclonal, HumanizedIndolesNasopharyngeal CarcinomaNasopharyngeal NeoplasmsNeoplasm Recurrence, LocalQuinolinesAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCirculating Tumor DNAFemaleHumansMaleMiddle AgedNeoplasm MetastasisProgression-Free SurvivalanlotinibAntibodies, Monoclonal, HumanizedCirculating Tumor DNAIndolesQuinolinestoripalimabanlotinibcirculating tumor DNAclinical trialnasopharyngeal carcinomarecurrent or metastatictoripalimab

Identifiers

PMID39615484
PMCPMC11722102

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

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.