NCT05311566

PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

Status unknown Phase 2 Last updated 13 April 2022

What this trial tests

Phase 2 trial testing Camrelizumab plus Concurrent chemoradiotherapy in Cervical Carcinoma in 92 participants. Status unknown.

Timeline

27 March 2022

Primary endpoint
27 March 2023

27 March 2026

Quick facts

Lead sponsor	Lei Li
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	92
Start date	27 March 2022
Primary completion	27 March 2023
Estimated completion	27 March 2026
Sites	1 location across China

Drugs / interventions tested

• Camrelizumab plus Concurrent chemoradiotherapy

Conditions studied

• Cervical Carcinoma — all drugs for Cervical Carcinoma →
• Chemoradiotherapy — all drugs for Chemoradiotherapy →
• Anti-programmed Cell Death Receptor 1 — all drugs for Anti-programmed Cell Death Receptor 1 →
• Immunotherapy — all drugs for Immunotherapy →

Sponsor

Lei Li — full company profile →

Who can join

18 and older, female only, with Cervical Carcinoma or Chemoradiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol. Subjects who finished treatment entered the safety follow-up or survival follow-up.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in cervical cancer: current insights and future directions.
   Xu M, Cao C, Wu P, Huang X, et al · · 2025 · cited 55× · PMID 39611440 · DOI 10.1002/cac2.12629
2. Human papillomavirus associated cervical lesion: pathogenesis and therapeutic interventions.
   Ye J, Zheng L, He Y, Qi X. · · 2023 · cited 27× · PMID 37719443 · DOI 10.1002/mco2.368
3. The anti-PD-1 era of cervical cancer: achievement, opportunity, and challenge.
   Li C, Cang W, Gu Y, Chen L, et al · · 2023 · cited 19× · PMID 37559727 · DOI 10.3389/fimmu.2023.1195476
4. Immune Environment and Immunotherapy in Endometrial Carcinoma and Cervical Tumors.
   Lainé A, Gonzalez-Lopez AM, Hasan U, Ohkuma R, et al · · 2023 · cited 10× · PMID 37046702 · DOI 10.3390/cancers15072042
5. Targeting immune microenvironment in cervical cancer: current research and advances.
   Zhang Z, Liu M, An Y, Gao C, et al · · 2025 · cited 6× · PMID 40781691 · DOI 10.1186/s12967-025-06896-3
6. The abscopal effect of immune-radiation therapy in recurrent and metastatic cervical cancer: a narrative review.
   Ollivier L, Moreau Bachelard C, Renaud E, Dhamelincourt E, et al · · 2023 · cited 6× · PMID 37539054 · DOI 10.3389/fimmu.2023.1201675
7. Immune checkpoint inhibitors in gynecologic oncology: Current status and perspectives.
   Yanaihara N, Tse KY, Lee SJ, Yoo JG, et al · · 2025 · cited 4× · PMID 40908776 · DOI 10.1002/ijgo.70280
8. Cancer Immunotherapy in Combination with Radiotherapy and/or Chemotherapy: Mechanisms and Clinical Therapy.
   Wang X, Jing J. · · 2025 · PMID 40900811 · DOI 10.1002/mco2.70346