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Uterine Diseases

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.

Participants will be given intravenous administration of Camrelizumab (200mg，every 2 weeks),Cisplatin(40mg/m²，everyweek) and Radiotherapy. After completing 6\~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.

Camrelizumab plus Concurrent chemoradiotherapy

Lei Li, M.D.

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.

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

Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study

Patient proportion to survival in the third year

The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs.

Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission（CR） and partial remission（PR）.

The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 5.0

Lei Li

Professor

Pharmaceutical Solutions

After pneumoperitoneum is established and laparoscopic instruments are prepared, according to National Comprehensive Cancer Network (NCCN) guidelines, 1ml diluted ICG solution (25 mg /10 ml) is injected into the submucosa around tumor at 3 and 9 o'clock of the cervix (2ml totally) with 1ml syringe. ICG should be slowly injected to avoid drug leakage. Intratumoral and deep cervical stroma injection should be avoided. The retroperitoneum is dissected immediately after injection under the multimodel observation of fluorescence laparoscopy. Search the fluorescent labeled lymphatics from bilateral parametrium to iliac vessels. The diffusion of ICG is rapid , and it is easy to spread to the next stations lymph nodes. The first fluorescent labeled lymph nodes on each lymphatic drainage pathway are identified as SLNs, other than all fluorescent lymph nodes. All detectable SLNs and enlarged or suspicious nodes regardless of mapping are resected for pathological examination alone.

Carbon nanoparticles

After pneumoperitoneum is established and laparoscopic instruments are prepared, according to NCCN guidelines, 0.5ml(25mg) carbon nanoparticle solution (the dose was from our retrospective study) is injected into the submucosa around tumor at 3 and 9 o'clock of the cervix (1ml totally) with 1ml syringe. Carbon nanoparticle should be slowly injected to avoid drug leakage. Intratumoral and deep cervical stroma injection should be avoided. The retroperitoneum is dissected immediately after injection. Search the black lymphatics from bilateral parametrium to iliac vessels. Because there is no fluorescence penetration as ICG, the black lymphatic vessels should be dissected carefully.The first black lymph nodes on each lymphatic drainage pathway are identified as SLNs, other than all black lymph nodes. All detectable SLNs and enlarged or suspicious nodes regardless of mapping are resected for pathological examination alone.

Indocyanine green

Bin Li, M.D.

Hongyi Hou, M.D.

The metastasis rate of pelvic lymph node in early cervical cancer is low. Systemic lymph node resection is traumatic and has many complications. Sentinel lymph node (SLN) biopsy can effectively avoid unnecessary lymph node dissection, which has been recommended in clinical guidelines. Indocyanine green(ICG) fluorescence imaging as the method of SLN mapping is recommended in international guidelines. However, the imaging equipment is very expensive which limits the popularization of ICG in different medical centers of various surgical volumes. Carbon nanoparticle is an innovative tracer without any special imaging equipment for SLN mapping in China. Some retrospective researches have proved that carbon nanoparticle is effective, simple, economic and suitable for popularization in different medical centers. In this study, a prospective randomized controlled trial will be conducted to analyze the non-inferiority of carbon nanoparticles compared to ICG, and to verify the application value of carbon nanoparticles. 144 cervical cancer patients with stage IB1 (FIGO2018) will be prospectively enrolled and randomly divided into two groups (R = 1:1). 72 patients will undergo SLN biopsy with carbon nanoparticles and 72 patients will be mapped by ICG. The primary endpoint is overall SLN detection rate. The secondary endpoints include bilateral SLN detection rate, the number of SLN detected, sensitivity, false negative rate and negative predictive value of SLN biopsy. Diagnostic accuracy will be evaluated at both pelvis and patient levels. What's more, SLN pathological ultrastaging will be conducted to increase the diagnostic accuracy. The hypothesis of this study is that the overall SLN detection rate by carbon nanoparticles is not inferior to that using ICG. And the differences of bilateral SLN detection rate, sensitivity, false negative rate and negative predictive value between two groups are not significant.

This is a prospective randomized controlled non-inferiority trial. Patients with early stage cervical cancer who met the inclusion criteria are divided into carbon nanoparticle group and ICG group by block random method. It is assumed that the overall SLN detection rate was PT (90%) in experimental group(carbon nanoparticle) and was PC (85%) in control group (ICG). The non-inferiority threshold Δ is -10%. The type I error and type II error of the hypothesis test are set as 0.05 and 0.2 respectively. The sample size is 60 cases in each group calculated by"Non inferiority tests for two proportions"method of Power Analysis and Sample Size (PASS) Software 11.0. After calculation, considering the 20% shedding rate, the sample size is 144 totally. There are 72 cases in experimental group and 72 cases in control group. Radical hysterectomy and systemic pelvic lymph node dissection are conducted after SLN resection, and paraaortic lymph node biopsy is conducted when necessary. Sentinel lymph nodes will be cut at 2-mm intervals perpendicular to the long axis in a bread-loaf fashion. Sentinel lymph nodes are then fixed in formalin and embedded in paraffin. Routine hemotoxin \& eosin(H\&E) staining is used for each SLN. Subsequent ultrastaging is performed if the initial H\&E assessment is negative. SLN ultrastaging is performed by cutting three 5-μm sections at two levels, 50-μm apart, from each paraffin block of negative SLN. At the first level, two adjacent 5-μm sections are stained with H\&E and immuno-histochemistry using the anti-cytokeratin AE1:AE3, respectively. At the second level, one 5-μm section is evaluated by H\&E staining. Nonsentinel lymph nodes are bisected parallel to the long axis and stained with H\&E staining.Nodal metastases are classified as (1) isolated tumor cells (ITCs) (single cells or clusters ≤ 0.2mm in largest dimension),(2) micrometastases (tumor deposits 0.2mm-2 mm), or (3) macrometastases (tumor deposits \> 2mm). All pathological reviews will be finished by two independent gynecologic pathologists in the Department of Pathology of Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College. A third senior pathologist is invited to decide the diagnosis when discordance occurs.

Carbon Nanoparticles and Indocyanine Green for Sentinel Lymph Node Biopsy in Early Stage Cervical Cancer

A Randomized Controlled Comparison Study of Carbon Nanoparticles and Indocyanine Green for Sentinel Lymph Node Biopsy in Early Stage Cervical Cancer

The time from the beginning of the operation to the end of the operation.

The amount of bleeding during the operation.

Adverse events, such as allergy, are caused by injection of tracers and defined according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

In this study, operative complications are defined according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

The percentage of patients with successfully detected SLNs in all eligible patients.

The percentage of patients with successfully detected SLNs in both sides of the pelvis in all eligible patients

The numbers of detected SLNs are calculated by the pathologist.

Distribution of SLNs in pelvic and abdominal cavity, including external iliac, obturator fossa, internal ilia, deep inguinal, common iliac, presacral, inferior vena cava, para-aortic, and parametrial regions.

The percentage of patients or pelvises with positive SLNs in pathological examination among those with positive pelvic lymph nodes.

The percentage of patients or pelvises with negative SLNs in pathological examination among those with positive pelvic lymph nodes.

The percentage of patients or pelvises with negative pelvic lymph nodes among those whose SLNs were negative in pathological examination.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

In group A exclusively sentinel lymphadenectomy is performed

in group B radical systematic pelvic lymphadenectomy is done. In patients with tumor free lymph nodes either radical hysterectomy or, in women seeking parenthood, radical trachelectomy is performed. If lymph nodes are tumor-involved systematic pelvic and paraaortic lymphadenectomy followed by primary chemoradiation is recommended.

Sentinel lymphadenectomy vs systematic pelvic lymphadenectomy

Lymphadenectomy in cervical cancer

Achim Schneider, Professor

Aim of present study is to inspect, if the removal alone of sentinel lymph nodes in women with early Cervix Carcinoma lead to, at equal length, overall survival like entire systematic dissection of lymph node and at the same time is accompanied with a considerably reduction of associated intra and post operative complications of lymph node dissection.

For this purpose were randomized about 1200 patients with histological assured cervix carcinoma in stages FIGO 1a1 L1 V0, FIGO 1a2 L0 or L1 V0, FIGO1b1 L0 or L1 V0= 2 cm randomization. In the branch A takes place exclusively dissection sentinel lymph node, in the branch B takes place entire pelvic lymph node dissection. Afterwards takes place in tumor free lymph nodes the removal of uterus by a radical hysterectomy or, in presence of the wish of children, radical trachelectomy. In affected tumoural lymph nodes takes place systematic pelvic and peri aortic lymph node dissection followed by primary Radiochemotherapy.

Primary end point is overall survival; this for both groups must be equal. Secondary end point is peri- and postoperative morbidity inclusive quality of life, the benefits for women must be evident with sentinel- lymph node dissection, don't have to show for both groups any significant difference.

After randomization and assignment to experimental or control group lymphadenectomy is carried out.

Four different techniques can be used: 1) laparoscopic transperitoneal 2) laparoscopic retroperitoneal 3) open extraperitoneal 4) open transperitoneal. Radioactive labeling of sentinel-lymph nodes with 99technetium-marked colloid and/or patent blue is carried out. On the day prior to the operation 50mBq 99technetium or on the day of operation 10 mBq 99technetium is injected subepithelially in the cervix at 12, 3, 6 and 9 o'clock. Preoperatively 4 cc patent blue are injected in the same manner subepithelially. At the beginning of surgery parametrial tumor involvement, intrabdominal tumor dissemination, invasion of vesica-cervical and recto-vaginal septum are excluded. A lavage of cul-de-sac for cytological analysis is performed. The retroperitoneum is opened lateral of iliac vessels and blue colored lymph or radioactive nodes are removed. Sentinel- lymph node's radioactive signal is documented in counts per second (cps).

If no sentinel-lymph node is detected, complete pelvic lymph node dissection is carried out. If tumor involved pelvic lymph nodes are shown, paraaortic lymph node dissection is carried out. If sentinel- or pelvic lymph nodes are quoted as tumor free at frozen sections, radical hysterectomy or radical trachelectomy is performed. Radical hysterectomy follows in an extension a type-2 variation. In patients with positive lymph nodes in frozen section or in definitive histo-pathology primary chemoradiation is performed.

Sentinel Concept in Early Stage Cervical Cancer

Prospective, Randomized and Multicentre Study for Investigation of Valence of Sentinel Lymph Nodes Concept in Patients With Cervical Cancer ≤ 2 cm

Primary study end point is that overall survival of patients with sentinel-concept, has not to differentiate from that one of patients with systematic lymph node dissection.

Secondary study end points are peri- und postoperative complications percentage and life quality after EORTC QLQ C-30 and local control. Local control percentage must exhibit no difference for both groups. Complications percentage and life quality must be significative better in branch with sentinel-lymph node dissection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer	NCT05311566	Cervical Carcin... Chemoradiothera... Anti-programmed... Immunotherapy Immune Checkpoi... Survival Outcom... Adverse Events Early Stage Cer... Locally Advance...	Camrelizumab pl...	18 Years -	Peking Union Medical College Hospital
Carbon Nanoparticles and Indocyanine Green for Sentinel Lymph Node Biopsy in Early Stage Cervical Cancer	NCT05167149	Cervical Cancer...	Carbon nanopart... Indocyanine gre...	18 Years - 70 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Carbon Nanoparticles and Indocyanine Green for Sentinel Lymph Node Biopsy in Early Stage Cervical Cancer	NCT05167149	Cervical Cancer...	Carbon nanopart... Indocyanine gre...	18 Years - 70 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sentinel Concept in Early Stage Cervical Cancer	NCT01157962	Cervical Cancer	Lymphadenectomy...	18 Years - 70 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for early stage cervical cancer