Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Recurrence

Uterine Cervical Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Paclitaxel

Albumin-Bound Paclitaxel

Immunomodulating Agents

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Immunologic Factors

The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.

A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients:

* Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months
* Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel

Lei Li, M.D.

For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Single Center, Open, Phase II Trial

The individual participant data will be available by public reports.

The rates of complete and partial remission

The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse

The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive.

The rates of complete and partial remission, and stable disease

The duration of complete and partial remission

The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Lei Li

Professor

Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months

Anti-PD-1 antibody camrelizumab

Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Albumin-bound paclitaxel

Lei Li, MD

This is a updated trial of NCT04188860 as a multi-center study. For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 122 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial

Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Multi-Center, Open, Phase II Trial

The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive

Carboplatin

Cisplatin

Eligible patients according to inclusion and exclusion criteria.

Patients will receive Donafenib (200mg, bid) combined with paclitaxel (135mg/m2) and cisplatin (creatinine clearance rate \> 60ml/min, 50 mg/m2) or paclitaxel (175 mg/m2) and carboplatin AUC=5 (40ml/min \< creatinine clearance rate \< 60ml/min) ± PD-1 antibody every 3 weeks.

Donafenib combined with paclitaxel and platinum ± PD-1 antibody

This study is to evaluate the safety and tolerability of Donafenib combined with paclitaxel and platinum ± programmed death 1 monoclonal antibody (PD-1 antibody) in patients with recurrent cervical cancer.

This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of Donafenib combined with paclitaxel and platinum ± PD-1 antibody in patients with recurrent cervical cancer. In total 20 patients will receive Donafenib (200mg, bid) combined with paclitaxel (135mg/m2) and cisplatin (creatinine clearance rate \> 60ml/min, 50 mg/m2) or paclitaxel (175 mg/m2) and carboplatin AUC=5 (40ml/min \< creatinine clearance rate \< 60ml/min) ± PD-1 antibody every 3 weeks.

Actual Study Start Date: March 27, 2022 Estimated Primary Completion Date: December 27, 2023 Estimated Study Completion Date: June 27, 2024

Arms There is only one arm, i.e., group of Donafenib combined with paclitaxel and platinum ± PD-1 antibody. Each treatment period was 21 days. Patients will be treated with 4-6 cycles of Donafenib plus TP or TC ± PD-1 antibody. After completion of the combination, patients will be maintained on Donafenib until disease progression or unacceptable toxicity occurs (up to 12 months)

Donafenib was taken orally at 200 mg twice on an empty stomach (1 hour before or \> 2 hours after meal) in the morning and evening of each administration day, with an interval of about 12 hours. Maintain the same dose until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antineoplastic therapy, or termination of treatment for other reasons specified in the protocol, for a maximum of 12 months.

Paclitaxel and platinum:

If creatinine clearance rate \> 60ml/min: on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 135 mg/m2plus cisplatin 50 mg/m2.

If 40ml/min \< creatinine clearance rate \< 60ml/min:on Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m2 plus carboplatin AUC=5.

PD-1 antibody: PD-1 antibody is not mandatory, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new antitumor therapy, or termination of treatment for other reasons specified in the protocol, the longest treatment period is 12 months.

The primary outcome measure is progression-free survival. The secondary outcome measures include overall survival, objective response rate, etc.

Donafenib for Recurrent Cervical Cancer

Efficacy and Safety of Donafenib Combined With Paclitaxel and Platinum in Patients With Recurrent, Metastatic, and Persistent Advanced Cervical Cancer: A Single-arm, Phase II Study

PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.

Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission.

DCR is defined as the percentage of participants in the analysis population who have a complete or partial remission, or stable disease (SD).

Adverse event (AE)、Treatment emergent adverse event (TEAE)、Serious adverse event (SAE).

Death

Disease Progression

Antibodies, Monoclonal

Immune Checkpoint Inhibitors

Radiotherapy for targeted lesions in all enrolled participants, with concurrent PD-1 antibody. Patients may or may not accept subsequent PD-1 as maintenance therapy.

Radiotherapy for targeted lesions and PD-1 antibody

This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.

PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer

Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study

Objective remission rate in one month after the end of radiotherapy

Progression-free survival after the end of radiotherapy

Overall survival after the end of radiotherapy

Severe adverse events during the radiotherapy and the follow-up stage

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel

A combination of cisplatin, paclitaxel and apatinib would be given for all patients:

* Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5)
* Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks
* Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6.

Chemotherapy plus apatinib

The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

A combination of cisplatin, paclitaxel and apatinib would be given for all patients

First-line Chemotherapy for Recurrent Cervical Cancer

Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy	NCT04188860	Recurrent Cervi... Persistent Adva... Chemotherapy Anti-PD-1 Antib... Immunotherapy	A combination o...	18 Years - 75 Years	Peking Union Medical College Hospital
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial	NCT05290935	Recurrent Cervi... Persistent Adva... Chemotherapy Immune Checkpoi... Anti-PD-1 Antib... Albumin-bound P...	Anti-PD-1 antib... Albumin-bound p...	18 Years - 75 Years	Peking Union Medical College Hospital
Donafenib for Recurrent Cervical Cancer	NCT05310331	Targeted Therap... Chemotherapy Recurrent Cervi... Metastatic Cerv... Persistent Adva... Survival Outcom... Adverse Effect	Donafenib combi...	18 Years - 75 Years	Peking Union Medical College Hospital
PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer	NCT05310305	Immune Checkpoi... Anti-programmed... Radiotherapy Recurrent Cervi... Metastatic Cerv... Persistent Adva... Objective Remis... Progression-fre... Overall Surviva... Severe Adverse ...	Radiotherapy fo...	18 Years -	Peking Union Medical College Hospital
First-line Chemotherapy for Recurrent Cervical Cancer	NCT04188847	Recurrent Cervi... Persistent Adva... Chemotherapy Vascular Endoth... Apatinib Targeted Therap...	Chemotherapy pl...	18 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for persistent advanced cervical carcinoma