CLINICAL TRIAL

Gemcitabine (gem) (Cohort A and B) for Adenocarcinoma

1 Prior Treatment
Metastatic
Recurrent
Stage I
Recruiting · 18+ · All Sexes · San Francisco, CA

This study is evaluating whether a combination of chemotherapy and immunotherapy may help treat pancreatic cancer.

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma · Pancreatic Adenocarcinoma Metastatic

Treatment Groups

This trial involves 2 different treatments. Gemcitabine (gem) (Cohort A And B) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Gemcitabine (gem) (Cohort A and B)
DRUG
+
Ipilimumab (Cohort A and B)
DRUG
+
Hydroxychloroquine (HCQ) (Cohort B)
DRUG
+
Nab-paclitaxel (nP) (Cohort A and B)
DRUG
Experimental Group 2
Gemcitabine (gem) (Cohort A and B)
DRUG
+
Ipilimumab (Cohort A and B)
DRUG
+
Nab-paclitaxel (nP) (Cohort A and B)
DRUG
+
Nivolumab (Cohort A)
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Adenocarcinoma or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Core Inclusion Criteria
Participant has histologically or cytologically documented diagnosis of pancreatic adenocarcinoma with metastatic disease. Participants with locally advanced disease are not eligible.
a. Participants with recurrent locally advanced disease are eligible, provided: i. the last dose of chemotherapy and/or radiotherapy occurred > 4 months prior to the first dose of study intervention, and; ii. no systemic or radiotherapy has been administered in the metastatic setting.
Participant must have measurable disease by RECIST v1.1.
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
A baseline tumor tissue sample is mandatory for enrollment. If archival tumor tissue is not available, then a fresh tumor biopsy must be provided.
Core
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2.5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2.5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2.5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Gemcitabine (gem) (Cohort A and B) will improve 1 primary outcome and 6 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of At 12 months.

Overall survival (OS) at 12 months
AT 12 MONTHS
Defined as the time from initiation of study intervention until death due to any cause.
AT 12 MONTHS
Disease control rate (DCR)
AT 9 MONTHS
Defined as the proportion of participants who achieve confirmed CR or PR or stable disease (SD) lasting at least 16 weeks
AT 9 MONTHS
Objective response rate (ORR)
UP TO 2.5 YEARS
Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
UP TO 2.5 YEARS
Overall survival (OS)
UP TO 2.5 YEARS
Defined as the time from initiation of study intervention until death due to any cause.
UP TO 2.5 YEARS
Incidence and severity of adverse events
UP TO 2.5 YEARS
UP TO 2.5 YEARS
Duration of response (DOR)
UP TO 2.5 YEARS
Defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease (PD) or death due to any cause.
UP TO 2.5 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for adenocarcinoma?

Adenocarcinoma is one of the most common forms of cancer. Most treatments are effective and can prevent metastases and cancer-related deaths. Adjuvant therapy with chemotherapy remains the key treatment for stage II lung adenocarcinoma.

Anonymous Patient Answer

How many people get adenocarcinoma a year in the United States?

Around 400,000 cases have been diagnosed with adenocarcinoma of the prostate. It is the second most common form of prostate cancer, with over 200,000 new cases expected to be diagnosed in the second half of this century.

Anonymous Patient Answer

What is adenocarcinoma?

Adenocarcinoma is a rare (around 1 per 10,000) but very aggressive cancer that tends to appear in and affect older smokers. The cause is unknown (although environmental carcinogens are present) but is thought to involve a defect in cell adhesion and cell division. Many adenocarcinomas have mutations of the KRAS oncogene, leading to activation of the RAS signalling pathway. Most adenocarcinomas are treated with surgery and platinum-based chemotherapy, and more than half are cured.

Anonymous Patient Answer

What are the signs of adenocarcinoma?

The main symptom of adenocarcinoma is weight loss. If a patient has persistent weight loss, and shows symptoms similar to weight loss, a biopsy should be performed. If this results in an adenocarcinoma diagnosis, then an alternative tumour should be considered, such as a primary intestinal T-cell lymphoma.

Anonymous Patient Answer

What causes adenocarcinoma?

The causes of adenocarcinoma are diverse, though smoking, genetics, and environmental factors are often implicated. Some of the other causes may result in either the conversion from a less aggressive cancer such as squamous cell cancer, to a more more aggressive form, such as adenocarcinoma.

Anonymous Patient Answer

Can adenocarcinoma be cured?

The success rate of treatment for adenocarcinoma is very high (more than 90%). The outcome appears to be worse if the cancer (stage III) presents at an advanced stage.

Anonymous Patient Answer

Does gemcitabine (gem) (cohort a and b) improve quality of life for those with adenocarcinoma?

(Group a and Group b) Overall, GEM significantly increased the median DAS-28 and PGA scores at one year. Significant improvements in QOL, global health and QOL physical health parameters were noted at three months (mean: 10.02, ±7.5 for group a; 10.12, ±8.26 for group b, respectively) and three months (mean: 10.0, ±9.2 for group a; 10.0, ±9.7 for group b, respectively). Improvement was noted in Group a (p =0.003) and in Group b (p =0.0001) at three months. Significant improvements were noted in Group a (p =0.

Anonymous Patient Answer

What are the latest developments in gemcitabine (gem) (cohort a and b) for therapeutic use?

Both cohorts had acceptable toxicity and antitumor activity. The addition of CpG ODN or Gd-DTPA to gem enhances its activity. The addition of CpG ODN is associated with enhanced toxicity. The current data, which are the first and largest of their kind, are encouraging, and warrant further studies to elucidate the effects of combination chemotherapy with gem.

Anonymous Patient Answer

Does adenocarcinoma run in families?

Because a significant proportion of AA families with adenocarcinoma may be explained by a recessive mode of inheritance, familial adenocarcinoma should not be classed as a classic autosomal or X-linked dominant disorder.

Anonymous Patient Answer

What is the latest research for adenocarcinoma?

There is insufficient evidence addressing the issues of the efficacy, safety and cost efficacy of treatment alternatives to surgery, and chemotherapy as primary therapeutic options for patients with locally advanced adenocarcinoma.

Anonymous Patient Answer

Who should consider clinical trials for adenocarcinoma?

Because adenocarcinoma seems to be a less aggressive tumor than either squamous cell carcinoma or non-small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), the data on response rates provided may be misleading. It will be important to look at other tumor types, such as neuroendocrine tumors, with noninvasive imaging modalities, and more data will be provided as we better understand the role of chemosensitivity in adenocarcinoma. However, even when the patient is considered in the most favorable circumstances, it appears that more than half the patients in our experience will undergo no-response evaluation, which may or may not be related to the cancer.

Anonymous Patient Answer

What is gemcitabine (gem) (cohort a and b)?

These clinical trial results suggest that gemcitabine should not be used as a monotherapy for patients with metastatic urothelial carcinomas of kidney but should be used in combination with other chemotherapy agents. The authors suggest further studies with high-quality design.

Anonymous Patient Answer
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