Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma

NCT03086681 | Completed Phase 2 DMC

• 1 other identifier: FirstGuangxiMU-2016-062
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. Patients were randomly divided into two groups, with 60 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locally advanced cervical carcinoma with high efficacy and low toxicity.

Conditions

Cervical Carcinoma

Keywords

Cervical carcinoma; endostar; concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• short-time effect

  3 months after treatment, the subjects go into observation period. MRI/CT will be used for evaluating the carcinoma status.

  3 months

Secondary Outcomes (2)

• Overall Survival

  3 years,5 years

• Progression-Free Survival

  3 years,5 years

Study Arms (2)

concurrent chemoradiotherapy + endostar

EXPERIMENTAL

4 cycles of Endostar and 5 cycles of DDP concurrent with radiotherapy

Drug: Endostar; Drug: DDP

concurrent chemoradiotherapy

ACTIVE COMPARATOR

5 cycles of DDP concurrent with radiotherapy

Drug: DDP

Interventions

Endostar DRUG

Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles

Also known as: recombinant human endostatin

concurrent chemoradiotherapy + endostar

DDP DRUG

DDP: 40mg /m2，per week, for 5 cycles

Also known as: cisplatin

concurrent chemoradiotherapy; concurrent chemoradiotherapy + endostar

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of either gender and aged from 18 to 65 years old.
• patients with histologically confirmed cervical carcinoma.
• patients at stage Ib, IIa2, IIb-IVa by FIGO 2009 staging.
• KPS ≥ 70 (Appendix I)
• patients with available MRI or CT data of cervical and measurable tumor lesions.
• patients did not receive any treatment before enrollment.
• patients with expected survival longer than 6 months.
• biochemical indexes: WBC \> 4,000/mm3, and blood platelet ≥ 100,000 mm3; PT≤UNL; levels of indicators for hepatic and renal function was 1.5 folds of the upper limit of normal value.
• the informed content was obtained from every patient.
• patients with effective follow-up.

You may not qualify if:

• those with malignant tumors other than cervical carcinoma.
• those received treatments before enrollmment.
• lactating women and Pregnant woman.
• those who were undergoing other drug trials.
• those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
• those who were treated with tumor targeting drugs.
• those who could not subject to MRI or CT examination.
• those who could not meet the requirements of the prescribed dose.

Sponsors & Collaborators

• Yong Zhang,MD: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related Publications (1)

• Wu F, Tang X, Liu W, Luo Z, Huang H, Liu M, Wang H, Liao S, Ma S, Jiang L, Zhang Y. Efficacy of Endostar plus concurrent chemoradiotherapy in locally advanced cervical cancer: a multicenter, phase II randomized trial. Ther Adv Med Oncol. 2025 Oct 3;17:17588359251379397. doi: 10.1177/17588359251379397. eCollection 2025.

  PMID: 41049580 DERIVED

Related Links

• Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262.
• Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa
• Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 2000;18:1
• Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med 1999;340:1137-1143.
• Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer.
• Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma.
• Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer
• A randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stages IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes
• Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis
• Clinical efficacy of modified preoperative neoadjuvant chemotherapy in the treatment of locally advanced (stage IB2 to IIB) cervical cancer: randomized study
• Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials
• Modern radiotherapy and cervical cancer.
• Quality of life (QOL) outcomes from a randomized trial of cisplatin versus cisplatin plus paclitaxel in advanced cervical cancer: a Gynecologic Oncology Group study
• A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer
• Role of angiogenesis in tumor growth and metastasis
• Antiangiogenic agents and their promising potential in combined therapy
• Function of endogenous inhibitors of angiogenesis as endothelium specific tumor suppressors
• Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung caner
• Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cerix: a gynecologic oncology group study
• Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: a phase III randomized trial of the Gynecologic Oncology Group
• Clinical potential of bevacizumab in the treatment of metastatic and locally advanced cervical cancer

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

endostar protein; Endostatins; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yong Zhang, MD

  First Affiliated Hospital of Guangxi Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: April 20, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)