Evidence map›Paper›PMID 41087995›Full record

ArticleBMC cancer2025

Safety and efficacy of toripalimab plus concurrent chemoradiotherapy for locally advanced cervical cancer: a single-arm, phase Ib trial.

Ping Jiang, Shuhua Wei, Chunxiao Li, Ang Qu, Hongbo Chen, Hua Zhang, Hongyan Guo, Junjie Wang

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04368273 (Phase I Study of Toripalimab Injection), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04368273 phase1 / phase2unknown statusnot on this map

Phase I Study of Toripalimab Injection (Pd-1 Antibody) With Cisplatin Concurrent IMRT for Local Advanced Cervical Cancer.

TypeinterventionalSponsorPeking University Third HospitalRan2020 to 2022Enrolled30ConditionsCervical CancerArmsPD-1 antibody
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

8 authors.

Ping Jiang *Department of Radiation Oncology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China.
Shuhua Wei *Department of Radiation Oncology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China.
Chunxiao Li *Department of Radiation Oncology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China.
Ang QuDepartment of Radiation Oncology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China.
Hongbo ChenDepartment of Radiation Oncology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China.
Hua ZhangResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.
Hongyan GuoDepartment of Gynecology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China. bysyghy@163.com.
Junjie WangDepartment of Radiation Oncology, Peking University Third Hospital, 49 North Huayuan Road, Beijing, 100191, China. junjiewang_edu@sina.cn.

Funding

Clinical scientist training program of Peking University BMU2023PYJH009Key Specialty program of the Natural Science Foundation of Beijing Municipality Z210008National Natural Science Foundation of China 82073335National Natural Science Foundation of China 82303804Postdoctoral Science Foundation of Guangxi Province of China 2023M730124Special Fund of National Clinical Key Specialty Construction Program of China 2021
6 · The paper itself

Abstract

backgroundAlthough two pivotal phase III trials have evaluated the efficacy of adding immune-checkpoint inhibitors (ICIs) to concurrent chemoradiotherapy (CCRT) in locally advanced cervical cancer (LACC), discrepancies between the two studies highlight the need for further exploration of ICIs combined with CCRT in this setting.

methodsTotally 30 patients with FIGO 2018 stage IB3-IVA cervical cancer were enrolled in this study. All patients underwent pelvic external beam radiotherapy (50.4 Gy in 28 fractions) followed by brachytherapy (30-36 Gy in 5-6 fractions), concurrent with cisplatin (40 mg/m² weekly) and toripalimab (240 mg every two weeks). The primary endpoint was adverse events, and secondary endpoints included the objective response rate (ORR) and progression-free survival (PFS). This trial is registered at ClinicalTrials.gov (NCT04368273) on April 25, 2020.

resultsTwenty-four patients (80%) experienced grade 3 or higher treatment-related adverse events (TRAEs). The most frequent ≥ grade 3 TRAEs were leukopenia (63%), lymphopenia (37%), and anemia (27%). One patient discontinued treatment due to immune-related hemophagocytic lymphohistiocytosis (HLH). Twenty patients (66.7%) experienced late radiation-related toxicities, including rectal hemorrhage (53.3%), hematuria (10%), and peripheral sensory neuropathy (13.3%). No treatment-related death occurred. All patients showed an ORR of 100% (95% [CI]: 0.85.9-1) as their best response. The 2-year PFS was 90% (95% CI 0.72-0.96). The median PFS was not reached with a 27.3-month follow-up.

conclusionsCombining toripalimab with CCRT had promising activity in LACC patients but might aggravate radiation-related adverse events and even cause serious immune-related adverse events. Therefore, ICIs therapy with CCRT needs further investigation.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyUterine Cervical NeoplasmsAdultAgedBrachytherapyCisplatinFemaleHumansMiddle AgedNeoplasm StagingTreatment OutcomeAntibodies, Monoclonal, HumanizedCisplatintoripalimabAnti-PD-1 therapyChemoradiation therapyImmunotherapyLocally advanced cervical cancerToripalimab

Identifiers

PMID41087995
PMCPMC12522217

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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 OpenQuestion graph.