Nab-PCE vs PC for MM After Failure of Anti-PD-1

STATUS

Recruiting
End date

Sep 30, 2022
participants needed

145
sponsor

Beijing Cancer Hospital

Send

Updated on 3 February 2022

See if I qualify

renal function

measurable disease

metastasis

brain metastases

Summary

This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin

Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin
endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma after failure of PD-1 therapy.

Description

The enrollment time is expected to be 1.5 year and the observation time is 2 years. The regimen were performed on a 28-day/21-day cycle respectively. Subjects who met the entry criteria were treated in a 2:1 group according to a randomized list: the treatment group was treated with nab-paclitaxel + carboplatin + endostatin regimen, and the control group was treated with paclitaxel + carboplatin. In this trial, the efficacy is evaluated every 8 weeks until disease progression or unacceptable toxicity,or until the investigator deemed that the patient's condition was unacceptable for further treatment. The follow-up period was 24 months after the end of treatment (follow-up patient survival information and new anti-tumor treatment). The planning enrolled sample size for nab-paclitaxel + carboplatin + endostatin group and paclitaxel-carboplatin group were 90 patients and 45 patients, respectively.

Details

Condition	Advanced Melanoma
Treatment	Chemotherapy, Chemotherapeutic Combinations
Clinical Study Identifier	NCT03917069
Sponsor	Beijing Cancer Hospital
Last Modified on	3 February 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18 years old, 70 years old, male or female
	Histological or pathological diagnosis of advanced melanoma, and progressed after anti-PD-1 treatment (disease progression or unacceptable toxicity)
	The patient has at least one (RECIST 1.1 standard) measurable lesion, which needs to be detected by spiral CT or MRI, and the tumor lesion has at least one single diameter 1 cm
	ECOG PS is 0 or 1 (see Annex 1 for standards)
	The estimated survival period is 12 weeks
	no chemotherapy contraindications, including normal peripheral blood, liver and kidney function and electrocardiogram are basically normal; Peripheral blood: neutrophils 1.5109/L, platelets90109/ L, hemoglobin90 g/L; Renal function: normal serum creatinine; For patients with non-metastatic liver function impairment: alanine, aspartate aminotransferase 2.5 ULN, For patients with metastatic liver dysfunction: alanine, aspartate aminotransferase 5 ULN
	Patients who have undergone topical treatment for asymptomatic brain metastases can be enrolled and have a clinical stable status of at least 4 weeks
	Patients voluntarily participate in and sign an informed consent form
	contraindications for the use of no carboplatin, paclitaxel, entropic and albumin paclitaxel
Exclusion Criteria
	Known HIV, hepatitis B/C virus positive status or history of active tuberculosis (testing prior to randomisation is not required)
	Received any investigational drug within 28 days or 5 half-lives of the planned first dose of this study treatment
	Active infection requiring systemic therapy
	A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low-risk of recurrence
	Patients with a history or evidence of cardiovascular risk
	History or evidence of interstitial lung disease or active non-infectious pneumonitis
	Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance
	Pregnant or breastfeeding females, or expecting to conceive or father children within the projected period of study treatment (52 weeks followed by 4 months following end of study treatment)

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

Nab-PCE vs PC for MM After Failure of Anti-PD-1