Clinical trial · Interventional
Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
Study of Pd-1 Antibody in Combination with Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. This is an open-label, single-arm, multi-center clinical trial to evaluate whether PD-1 in combination with neoadjuvant chemotherapy will achieve better objective response rate.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- Patients receive 1 cycle of cisplatin and albumin-bound paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of PD-1 antibody combined neoadjuvant chemotherapy.
- interventionNames
- Drug: Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 3 months
- description
- ORR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The ORR will be assessed by a blind independent central reviewer per RECIST 1.1
Secondary outcomes (3)
- measure
- Pathological response rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with locally advanced (2018 FIGO staged IB3, IIA2 and IIB/IIIC1r(tumor size ≥ 4cm) ) cervical cancer and had not received any treatment before. 2. Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix. 3. Pathological examination of the PD-L1 positive(Combined score Positive Score≥1). 4. Females 18-70 years of age. 5. Eastern Cooperative Oncology Group score 0-1. 6. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value. 7. Well-compliance and willing to keep in touch. 8. Willing to participate in this study, and sign the informed consent. Exclusion Criteria: 1. Active or known or suspected autoimmune disease requires a system treatment as follows but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators. 2. HIV infection, active HBV/HCV. 3. Condition requiring systemic treatment with small doses of corticosteroids within 1 months or large doses of corticosteroids within 3 months prior to randomization. 4. Any primary malignancy within 5 years. 5. Participate in other drug clinical trials at the same time. 6. Pregnant or lactating female patients. 7. Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery. 8. Drug or alcohol abuse. 9. Unable or unwilling to sign informed consents. 10. Not eligible for the study judged by researchers.
References
Publications (3)
- DERIVEDLi K, Chen J, Hu Y, Wang YZ, Shen Y, Chen G, Peng W, Fang Z, Xia B, Chen X, Song K, Wang Y, Zou D, Wang YC, Han Y, Feng X, Yuan J, Guo S, Meng X, Feng C, Chen Y, Yang J, Fan J, Wang J, Ai J, Ma D, Sun C. Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Jan;25(1):76-85. doi: 10.1016/S1470-2045(23)00531-4. Epub 2023 Dec 1. PMID 38048802
- DERIVEDFan J, Lu F, Qin T, Peng W, Zhuang X, Li Y, Hou X, Fang Z, Yang Y, Guo E, Yang B, Li X, Fu Y, Kang X, Wu Z, Han L, Mills GB, Ma X, Li K, Wu P, Ma D, Chen G, Sun C. Multiomic analysis of cervical squamous cell carcinoma identifies cellular ecosystems with biological and clinical relevance. Nat Genet. 2023 Dec;55(12):2175-2188. doi: 10.1038/s41588-023-01570-0. Epub 2023 Nov 20. PMID 37985817
- DERIVEDChen J, Han Y, Hu Y, Feng X, Meng X, Guo S, Sun C, Chen G, Li K. Neoadjuvant camrelizumab plus chemotherapy for locally advanced cervical cancer (NACI Study): a study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 May 30;13(5):e067767. doi: 10.1136/bmjopen-2022-067767. PMID 37253491